SHANGHAI APOLO MEDICAL TECHNOLOGY CO., LTD.
⚠️ Moderate Risk
FEI: 3007120647 • Shanghai, Shanghai • CHINA
FEI Number
3007120647
Location
Shanghai, Shanghai
Country
CHINAAddress
Building 11, Lane 1566, Nanle Road, Songjiang District, , 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
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.
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).
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.
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
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).
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 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).
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/20/2021 | 79PKTLASER FOR DISRUPTION OF ADIPOCYTE CELLS FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 7/30/2020 | 79ONFPOWERED LIGHT BASED NON-LASER SURGICAL INSTRUMENT WITH THERMAL EFFECT | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/30/2014 | 79MYHSYSTEM, NON-COHERENT LIGHT, PHOTODYNAMIC THERAPY | Los Angeles District Office (LOS-DO) | |
| 3/14/2014 | 79ONFPOWERED LIGHT BASED NON-LASER SURGICAL INSTRUMENT WITH THERMAL EFFECT | 2780DEVICEGMPS | Cincinnati District Office (CIN-DO) |
| 4/4/2011 | 79FTCLIGHT, ULTRAVIOLET, DERMATOLOGICAL | New York District Office (NYK-DO) |
Frequently Asked Questions
What is SHANGHAI APOLO MEDICAL TECHNOLOGY CO., LTD.'s FDA import refusal history?
SHANGHAI APOLO MEDICAL TECHNOLOGY CO., LTD. (FEI: 3007120647) has 5 FDA import refusal record(s) in our database, spanning from 4/4/2011 to 9/20/2021.
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 APOLO MEDICAL TECHNOLOGY CO., LTD.'s FEI number is 3007120647.
What types of violations has SHANGHAI APOLO MEDICAL TECHNOLOGY CO., LTD. received?
SHANGHAI APOLO MEDICAL TECHNOLOGY CO., LTD. has been cited for 8 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 APOLO MEDICAL TECHNOLOGY CO., LTD. come from?
All FDA import refusal data for SHANGHAI APOLO MEDICAL TECHNOLOGY 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.