Shanghai Amsino Medical Devices Co., Ltd.
⚠️ Moderate Risk
FEI: 3003238685 • Shanghai, Shanghai • CHINA
FEI Number
3003238685
Location
Shanghai, Shanghai
Country
CHINAAddress
No 5 Huajiang Road, , 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).
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.
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 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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/26/2013 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/30/2013 | 80BRZSET, BLOOD TRANSFUSION | Division of Southeast Imports (DSEI) | |
| 7/25/2013 | 80BRZSET, BLOOD TRANSFUSION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 7/9/2013 | 80BRZSET, BLOOD TRANSFUSION | Division of Southeast Imports (DSEI) | |
| 7/9/2013 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 7/5/2013 | 80BRZSET, BLOOD TRANSFUSION | Division of Southeast Imports (DSEI) | |
| 7/5/2013 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/6/2013 | 80BRZSET, BLOOD TRANSFUSION | 118NOT LISTED | Florida District Office (FLA-DO) |
| 1/7/2013 | 80BRZSET, BLOOD TRANSFUSION | Division of Southeast Imports (DSEI) | |
| 12/10/2012 | 80BRZSET, BLOOD TRANSFUSION | Division of Southeast Imports (DSEI) | |
| 10/1/2012 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/13/2012 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/24/2011 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 118NOT LISTED | Florida District Office (FLA-DO) |
| 4/17/2011 | 80BRZSET, BLOOD TRANSFUSION | Division of Southeast Imports (DSEI) | |
| 4/17/2011 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/17/2011 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/12/2011 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 118NOT LISTED | Florida District Office (FLA-DO) |
| 1/10/2011 | 80BRZSET, BLOOD TRANSFUSION | 118NOT LISTED | Florida District Office (FLA-DO) |
| 1/10/2011 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 118NOT LISTED | Florida District Office (FLA-DO) |
| 12/30/2010 | 80BRZSET, BLOOD TRANSFUSION | 237NO PMA | Florida District Office (FLA-DO) |
| 12/30/2010 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/8/2010 | 80BRZSET, BLOOD TRANSFUSION | Division of Southeast Imports (DSEI) | |
| 8/23/2010 | 80BRZSET, BLOOD TRANSFUSION | 341REGISTERED | Florida District Office (FLA-DO) |
| 7/26/2010 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 118NOT LISTED | Florida District Office (FLA-DO) |
| 4/5/2010 | 78FAQBAG, URINE COLLECTION, LEG, FOR EXTERNAL USE | Division of Southeast Imports (DSEI) | |
| 12/18/2006 | 78FCEKIT, ENEMA, (FOR CLEANING PURPOSE) | New York District Office (NYK-DO) | |
| 10/19/2005 | 78GBMCATHETER, URETHRAL | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 10/19/2005 | 79HTDFORCEPS | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 10/19/2005 | 80KYZSYRINGE, IRRIGATING | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 10/19/2005 | 78KNYACCESSORIES, CATHETER, G-U | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 10/15/2005 | 80KYZSYRINGE, IRRIGATING | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/15/2005 | 78LJHSYSTEM, IRRIGATION, UROLOGICAL | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/15/2005 | 78LJHSYSTEM, IRRIGATION, UROLOGICAL | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/15/2005 | 78LJHSYSTEM, IRRIGATION, UROLOGICAL | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 8/4/2005 | 78LJHSYSTEM, IRRIGATION, UROLOGICAL | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 8/4/2005 | 79GCYAPPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 8/4/2005 | 80KYZSYRINGE, IRRIGATING | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 8/4/2005 | 79HXDCLAMP | 341REGISTERED | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Shanghai Amsino Medical Devices Co., Ltd.'s FDA import refusal history?
Shanghai Amsino Medical Devices Co., Ltd. (FEI: 3003238685) has 38 FDA import refusal record(s) in our database, spanning from 8/4/2005 to 9/26/2013.
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 Amsino Medical Devices Co., Ltd.'s FEI number is 3003238685.
What types of violations has Shanghai Amsino Medical Devices Co., Ltd. received?
Shanghai Amsino Medical Devices Co., Ltd. has been cited for 5 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 Amsino Medical Devices Co., Ltd. come from?
All FDA import refusal data for Shanghai Amsino Medical Devices 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.