Shanghai Poly Technologies Co., Ltd.
⚠️ Moderate Risk
FEI: 3003441816 • Shanghai • CHINA
FEI Number
3003441816
Location
Shanghai
Country
CHINAAddress
446 Zhao Jia Bang Rd.,8/F., Yitaili, , Shanghai, , China
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
NO TAG
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product to which is not affixed a certification in the form of a label or tag in conformity with section 534(h).
NO PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/3/2013 | 79OUHSKIN RESURFACING RF APPLICATOR | San Francisco District Office (SAN-DO) | |
| 12/3/2013 | 95REAHIGH-POWER LASER LIGHT SHOW PROJECTOR (OUTPUT>5MW) | San Francisco District Office (SAN-DO) | |
| 12/3/2013 | 79MUUSYSTEM, SUCTION, LIPOPLASTY | San Francisco District Office (SAN-DO) | |
| 12/3/2013 | 79OUHSKIN RESURFACING RF APPLICATOR | San Francisco District Office (SAN-DO) | |
| 12/3/2013 | 76EHDUNIT, X-RAY, EXTRAORAL WITH TIMER | San Francisco District Office (SAN-DO) | |
| 12/3/2013 | 77ESDHEARING-AID, AIR-CONDUCTION | San Francisco District Office (SAN-DO) | |
| 12/3/2013 | 86HLMINSTRUMENT, MEASURING, LENS, AC-POWERED | San Francisco District Office (SAN-DO) | |
| 12/3/2013 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | San Francisco District Office (SAN-DO) | |
| 12/3/2013 | 79OUHSKIN RESURFACING RF APPLICATOR | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Shanghai Poly Technologies Co., Ltd.'s FDA import refusal history?
Shanghai Poly Technologies Co., Ltd. (FEI: 3003441816) has 9 FDA import refusal record(s) in our database, spanning from 12/3/2013 to 12/3/2013.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Shanghai Poly Technologies Co., Ltd.'s FEI number is 3003441816.
What types of violations has Shanghai Poly Technologies Co., Ltd. received?
Shanghai Poly Technologies Co., Ltd. has been cited for 7 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Shanghai Poly Technologies Co., Ltd. come from?
All FDA import refusal data for Shanghai Poly Technologies Co., Ltd. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.