Have you been doing research on Sono Star Technologies Co Ltd in Guangzhou located in China sells Medical Ultrasound? If so, read on below to read one buyers experience when trying to buy Medical Ultrasound.
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Sono Star Technologies Co Ltd in Guangzhou
Room 504A, 5th Floor, Building C, No.27 Yayingshi Road, Science City, High-tech Industrial Development Zone, Guangzhou City, Province, NO27, China
Initial contact with the supplier:
Type of product(s) being purchased:
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:
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.
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.
Regardless of the industry and Notified Bodies, no amount of DD is enough when working with Chinese manufactures or suppliers if you want to avoid the “Beijing Two-Step”
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