Shanghai Wonderful Opto-Electrics Tech. Co., Ltd.
⚠️ Moderate Risk
FEI: 3004505220 • Shanghai, Shanghai • CHINA
FEI Number
3004505220
Location
Shanghai, Shanghai
Country
CHINAAddress
(E) Building F 2, 2F, Building 9, Lane 561, Nujiang Road ((North), Shanghai, 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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
NON STD
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 offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
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.
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/6/2020 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Division of Southeast Imports (DSEI) | |
| 4/26/2018 | 74MNOSYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION | Division of Southeast Imports (DSEI) | |
| 7/16/2013 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Seattle District Office (SEA-DO) | |
| 11/23/2005 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 476NO REGISTR | Seattle District Office (SEA-DO) |
| 9/16/2004 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Shanghai Wonderful Opto-Electrics Tech. Co., Ltd.'s FDA import refusal history?
Shanghai Wonderful Opto-Electrics Tech. Co., Ltd. (FEI: 3004505220) has 5 FDA import refusal record(s) in our database, spanning from 9/16/2004 to 8/6/2020.
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 Wonderful Opto-Electrics Tech. Co., Ltd.'s FEI number is 3004505220.
What types of violations has Shanghai Wonderful Opto-Electrics Tech. Co., Ltd. received?
Shanghai Wonderful Opto-Electrics Tech. Co., Ltd. has been cited for 10 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 Wonderful Opto-Electrics Tech. Co., Ltd. come from?
All FDA import refusal data for Shanghai Wonderful Opto-Electrics Tech. 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.