SonoStar Technologies Co. Ltd.

Onsite visit for meeting with owner and discussion of contractual terms for ODM and OEM services. Address of meeting at the time was only address listing for business. Following hours of discussions/interpreting, request to inspect manufacturing facility that was stated to be at same location, however, resulted in “manufacturing at another location.” First indication something was not correct.

SonoStar Technologies Co. Ltd.

Buyer’s Nationality:
United States

Seller:
SonoStar Technologies Co. Ltd.

Seller Website:
www.sonostarmed.com, www.sonostar.net

Seller Address:
#27 Yayingshi Road, 504#, C Building, Science Town, Guangzhou, China

Initial contact with the supplier:
Online Supplier Directory

Type of product(s) being purchased:
OEM services, purchase of ultrasound unit sample

Value of the Purchase Order when the incident occurred:
6,001 to 12,000 USD

Destination market of order in question:
US or Canada

Type of Complaint(s):
compromised intellectual property, scams & other unethical activities

Stage of relationship with the supplier at the time of the incident:
Sampling/Testing

User Experience:
Onsite visit for meeting with owner and discussion of contractual terms for ODM and OEM services. Address of meeting at the time was only address listing for business. Following hours of discussions/interpreting, request to inspect manufacturing facility that was stated to be at same location, however, resulted in “manufacturing at another location.” First indication something was not correct.

Unable to travel to the address stated as manufacturing due to continued delay of initial meeting, travel plans required a return trip. It was agreed to initiate first production unit for quality evaluation. All certificates, ISO/CE, business licenses, etc., were copied and “appeared” to be correct and in-order, which is what led to initial production run.

3 months later, production unit was confirmed as completed with images delivered. Travel plans to China again only to arrive on-site with claim “sorry, the unit is with another client.” Not good considering manufacture design was per my company specs. Departure was extended x2 as thought a communication error with between “client” and “agent.” Delay in my company’s departure was not announced and we returned to Sonostar without notice. requested to inspect manufacturing facility, which was received with multiple excuses as to why this was not possible. After insistence, address was finally delivered after hours. Although Sonostar expected my company had to depart the following day, we traveled to the address we were given for manufacturing only to find a black-market device manufacturer actively copying other company med device units.

After some discussions with the facility, we acquired multiple copies of certificate books, licenses, etc. Outcome after having multiple 3rd party verification is still correct:

Sonostar is not licensed to produce, manufacture, of sell any medical equipment/devices. Sonostar is only licensed in china as a trade company and not medical devices, but electronic components for TV’s (according to local licenses). All licenses, TUV, CE mark, and other notified body certificates are fraudulent and use multiple correct cert numbers, but of expired or blacklisted companies.

Currently we find our product design offered by multiple suppliers with stated manufacturer of “sonostar.”

User Recommendations:
Even after receiving certificates and confirming on database links, ensure the source code of the page you are linked to is actually that of the notified body. We found that the notified body database for CE Mark and TUV had been mirrored. this likely would have been avoided if checks were not completed within China.

The cost of 2 extended trips to China are well worth it when dealing with Chinese OEM/ODM of significant value. Only saving grace on this is that the design requested was not our actual final stage production design. This allows us to launch our 3rd generation design so that it will not be comparable to a fraudulent copy.

 

15 comments on “SonoStar Technologies Co. Ltd.”

  1. RE: SonoStar Technologies Co. Ltd.
    In response to the statement issued by “Vita” that challenges the validity of the posting, we offer the below reply.
    First and foremost, it should be well understood that the original posting is dated August 25, 2016, which is 2 years ago. As such, the subjects of “…TUV in 2017” and “FDA certification in 2018” have zero relevance as it relates to the original complaint.
    As posted in 2016, the statements were made following intensive due diligence (DD) performed internally by our company agents within China, as well as an independent verification company. A portion of the results of our DD is described in-part as follows:
    1. Official Company Name: 广州索诺星信息科技有限公司
    Registered May 16, 2011
    Registration Bureau: Guangzhou AIC, Luogang Branch广州市工商行政管理局萝岗分局
    Registration Number: 91440116574031770P
    Registered Address: Room 504A, 5th Floor, Building C, No.27 Yayingshi Road, Science City, High-tech Industrial Development Zone, Guangzhou City, Guangdong Province, China

    Business Scope Allowed:
    Technology development and service of computers;
    Retail trade of goods (excluding items subject to administrative permit or approval – which would be medical devices);
    Design service of electronic products;
    Import and export of technology;
    Wholesale trade of goods (excluding items subject to administrative permit or approval);
    Import and export of goods (excluding State controlled or franchised items – medical devices are State controlled);
    Information consulting service of goods.
    计算机技术开发、技术服务;商品零售贸易（许可审批类商品除外）;电子产品设计服务;技术进出口;商品批发贸易（许可审批类商品除外）;货物进出口（专营专控商品除外）;商品信息咨询服务;

    2. As per “our company obtained the CE certification issued by GK Test organization in 2013 (certification No. B-S07008047)” – There is much detail on this single item, so please read carefully, Vita:

    Items are addressed per “Red Letters” that are placed on image of said CE certificate (Links here for reference is an original copy http://imgbox.com/OadNl4mq along with a lettered copy http://imgbox.com/DRRsRI7w that was on display on SonoStar’s websites as well as on display within company physical location as follows:

    Issuing Company Discrepancy: The Certificate of Compliance was determined to be fake in part due to the great variance in issuing body corporate name, identified by letters A, E, F

    A: GK Compliance Laboratory http://imgbox.com/gGcynihb
    E: “Corporate Seal” states “GK Product Service Limited” http://imgbox.com/Gg7hmj2f
    F: GK Test Service Limited http://imgbox.com/zpOPM3lG

    Which is it? Apparently the “test” company is not sure of its own name, perhaps. At any rate, the issuing company is purported to be a UK corporation. As such, UK government database was searched at length for all possible matches of the various names used on the certificate. All names were found to not match any UK registered corporation, active, or otherwise.

    H: Company registration number as stated on certificate is associated with a Chinese based holding company and registered under the name of “Marine Ally International Trade Logistic Co. Ltd., and has been dissolved since 2012 Link here: http://imgbox.com/e8stxvpI

    B: Certificate Number identified by letter “B” as B-S07008047 could not be identified in any notified body database

    C: Title of certificate reads “EC Certificate of Conformity”. It has been determined EC is a typo

    D: Signature block is signed only as “Michael” and without a surname which is highly suspicious

    G: And finally, we come to the issuing company address of “10 Coptic Street…” – This address is a residential address and has not been associated with any registered UK company. For reference, and for entertainment, an image of the location is found here: http://imgbox.com/6bVapnWl

    To conclude this rebuttal, please understand, Vita, and associated SonoStar, that this includes only the details of the “CE Certificate” that you stated you received in 2013, never mind the fact that the date on this actually reads “2014”. For reference, our DD file on your company contains 1.3G of data. Imagine all that can be described in great detail, considering I have only outlined a single “certificate”.

    Should you, Vita, and SonoStar, Mr. Cai, et al, wish to further challenge the statements made as they pertain to the posting date of August 25th, 2016, I would be more than happy to continue this most entertaining educational presentation of facts.

    I will remind you that production, promotion, and selling, a medical device globally and failing to report such activity prior to submission of FDA 510(k) is absolute grounds for being blacklisted by the FDA as well as being barred from subsequent applications as a so called “manufacturer” of regulated devices, be it Class I, II, or III.

    According to our same DD investigation, you, i.e. SonoStar, have conducted such activity as related to “U-Probe” since 2015 and I am more than happy to follow up with the FDA advisory board should your incessant demands to have our complaint removed continue.

    With that, Best of Luck to you.

    2. Dear sir :
      Is there any reply about my comment in September 21th?
      Can you delete this untrue description？

      Thanks
      Vita
      Mob/ whatsapp/wechat : +86 18620509612
      Skype:vitayang12
      Email:sales6@sonostar.net

      2. This will be the last reply in support of the original posted complaint as the historical FACTS that supported our original finding for complaint have not, and will not change. To quote our original posting, please consider actually reading the following statement: “First and foremost, it should be well understood that the original posting is dated August 25, 2016, which is 2 years ago.”
        With consideration for the above statement, the excuses offered on September 21, 2018, by Sonostar/ Vita, only support, not invalidate, the original complaint. Any certification, legitimate or not, and obtained post 2016 is irrelevant as this is after the fact and is beyond the scope of the complaint.
        Instead of offering excuses contained within the replies from Sonostar, the simplest way to have invalidated the original complaint would be to have provided proof that the CE Mark certificate of conformity was authentic. This would have been an easy process should Sonostar be a professional and legitimate Medical Device Manufacturer. However, by trying to support their historical unethical and fraudulent business practices, Sonostar has provided statements that only substantiate the original complaint.
        As stated in our previous port, we would be happy to provide our findings to the U.S. FDA and as such, we will oblige by submitting a formal complaint for review. Our recommendations for you, Vita and Sonostar, is to engage with a skilled consultant that can help you navigate the upcoming audits. We know a couple of good ones, feel free to ask for a referral.
        For those interested in facts and entertainment value, please read on………
        “1. For the certificate, we have not made a fake. The CE certification that GK Company made for us, we paid the certification fee to them and obtained their certificate. If there is a problem with their qualifications, we are not aware of it. This customer can and should complain to GK instead of complaining about us.
        Not long after that, we know that they are not so authoritative, so we changed to CE certification by German TUV and obtained a new certificate issued by them (see attachment).”
        There are a couple of points we will make from the above statement:
        • “For the certificate, we have not made a fake” – Original complaint did not accuse Sonostar of generating a fake CE certificate. Creating a fake certificate is not an issue nor was it an accusation contained within the original complaint.
        • “The CE certification that GK Company made for us, we paid the certification fee to them and obtained their certificate.” – So Sonostar did not make the fake certificate, they simply purchased it. That helps. Obtaining a fake certificate and advertising it as legitimate is the problem. Not only is this unethical, it is illegal and constitutes fraud. Marketing/distribution of Class II medical devices to Europe for human use under falsified CE Mark is not only dangerous for patients, it also equates to heavy fines and an easy prison sentence should Notified Bodies care to investigate.
        • “This customer can and should complain to GK instead of complaining about us.” – One cannot level complaints to a company that does not exist, therefore, we could not complain to “GK” even if we felt such action was warranted, which it is not considering we have never conducted any business transactions with said “company”.
        • “If there is a problem with their qualifications, we are not aware of it.” – This statement is interesting as it is immediately followed by “we know they are not so authoritative” in the very next paragraph. In our opinion, these two statements highlight the dishonest nature of Sonostar’s business practices.
        Furthermore, as the self-proclaimed manufacturer of a medical device, you bear the responsibility of ensuring the qualification(s) and/or certifications of agents, i.e. contractors, subcontractors, suppliers, etc., are valid.

        • “Not long after that, we know that they are not so authoritative, so we changed to CE certification by German TUV…” – How long after knowing you had a fake CE Mark, Vita? You stated it was received in 2013 (regardless of the fact the date on the fake certificate is 2014), and received a legitimate CE Mark via TUV in….2018. 5 years following the fake one, 2 years after the date of the original complaint. During which of the 5 years would be “not long after that” did Sonostar become aware of the fact they were advertising false CE Mark?

        2. The customer said that we did not write the production in the business scope of the industrial and commercial registration certificate in China. This does not mean that we have no qualification for production. The production of medical equipment in China has a special qualification, which is a production license. This is not issued by the Trade and Industry Bureau. It was issued by the Food and Drug Administration. We have obtained this production license in 2013. See the attached certificate and English translation.
        • “This does not mean that we have no qualification for production.” – We agree on this item, but will add that you have no qualification for production of medical devices simply because you have no production facility at the addressed location of your business, that your license is attached to.
        • “The production of medical equipment in China has a special qualification, which is a production license. This is not issued by the Trade and Industry Bureau. It was issued by the Food and Drug Administration. We have obtained this production license in 2013. See the attached certificate and English translation.” – We do not agree with your self-translation of the provided document. What you have on copy is something that any so called “company” could obtain in 2013-2014 as it required nothing more but registration. In our opinion, amended State Council Order No. 650, is a root cause of the proliferation of fraudulent companies such as yours, in that this type of license could be obtained by any “company” selling a registered device manufactured by another company, hence, the term trading company. An issue that hopefully is corrected by the newest amendments.

        • “The complaint is inaccurate and the reasons are not sufficient.” – The complaint is accurate and fact based.

        • “We are not at fault.” – Of course you are.

  2. Dear webmaster:
    Please help to help delete this post, because the malicious speculation of competitors, the description of the false information, will have a negative impact on our company.
    Otherwise, our company will retain the rights of responsibility.
    Thank you.

        1. The buyer who made the original listing has just posted a very detailed rebuttal of your comments, which support his original listing. Please review and we welcome you to post your response.

          1. For the complainant, we make the following explanation:
            1. For the certificate, we have not made a fake. The CE certification that GK Company made for us, we paid the certification fee to them and obtained their certificate. If there is a problem with their qualifications, we are not aware of it. This customer can and should complain to GK instead of complaining about us.
            Not long after that,we know that they are not so authoritative, so we changed to CE certification by German TUV and obtained a new certificate issued by them (see attachment).

            2 The customer said that we did not write the production in the business scope of the industrial and commercial registration certificate in China. This does not mean that we have no qualification for production. The production of medical equipment in China has a special qualification, which is a production license. This is not issued by the Trade and Industry Bureau. It was issued by the Food and Drug Administration. We have obtained this production license in 2013. See the attached certificate and English translation.

            The complaint is inaccurate and the reasons are not sufficient. We are not at fault .Then please remove the relevant content on your website as soon as possible.
            Thanks.

          2. Dear Administer:
            I have post reply 7 days ago,
            could I know any update? When will your website remove this article ？

            Thanks

          3. Thanks for your comments and reply. Please know that the buyer has submitted a very detailed rebuttal of your comments supporting their position. Please see their comments and reply in detail as the case does not appear to be as black and white as you claim. Thanks in advance for offering a “rebuttal” of the buyer’s “rebuttal”.

  4. We found that your website posted a complaint content about our company as below link: https://www.supplierblacklist.com/2016/08/25/sonostar-technologies-co-ltd/?from=singlemessage
    We carefully checked all the contents and found that they were all fabricated.
    Including the certification mentioned inside is false: our company obtained the CE certification issued by GK Test organization in 2013 (certification No. B-S07008047), the CE certification issued by TUV in 2017 (certification No. G1161295448002), and FDA certification in 2018. (certification No. K172750), we provide these officially obtained certificates to our customers without any fake certificate.
    It is mentioned in the complaint content that they have visited our company many times and our people took them to an informal place to check our production site, all these have never happened. Our company has only one production site, and this production site got the license of medical device production which certified by the drug regulatory department. We never had an informal production site. Customers who have visited our company are all pleasant and satisfied. There has never been a contradiction between our company and clients.
    Regarding customer’s OEM requirements, our consistent principle is accepting the order base on checking our production status firstly. If production capacity is not allowed ,we will not accept the order, but if we had promised our customers about the delivery, we will complete the order as promise without any delay or change.
    In addition, the content also stated that the scope of our business we registered in China is only the daily electronic product trade, this is purely filthy. We obtained the medical device production license in 2013 (License No. 20132454, No. 20132454).
    You can ask those who provide these false information to present proof materials.
    Including photos, mail records, itinerary records and related certificate documents which they can’t provide.
    We suspect that the complaint content comes from our competitors who want to discredit us.
    It is an irresponsible act and a violation of the law to publish such false and reputable information without verification or confirmation from us.
    We formally request you:
    1. Delete all the related content within 2 days;
    2. Apologize to us and compensate for the loss of reputation;
    3. Send us the information about the person who submitted these false information to you,we will hold him legally responsible

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