Micro-Tech (Nanjing) Co., Ltd.
⚠️ High Risk
FEI: 3004837686 • Nanjing • CHINA
FEI Number
3004837686
Location
Nanjing
Country
CHINAAddress
High Tech, No. 10 Gaoke Third Road Nanjing National, Nanjing, , China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
3905
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).
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.
STERILITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/20/2025 | 79NCADEVICE, SUTURING, STAPLING, GRAFT, AORTIC | Division of Southeast Imports (DSEI) | |
| 9/2/2025 | 78FDISNARE, FLEXIBLE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 9/2/2025 | 78FDISNARE, FLEXIBLE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 9/2/2025 | 78FDISNARE, FLEXIBLE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 8/26/2025 | 78FDISNARE, FLEXIBLE | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 7/15/2025 | 78FDISNARE, FLEXIBLE | Division of Northern Border Imports (DNBI) | |
| 7/15/2025 | 78FDISNARE, FLEXIBLE | Division of Northern Border Imports (DNBI) | |
| 7/15/2025 | 78FDISNARE, FLEXIBLE | Division of Northern Border Imports (DNBI) | |
| 7/15/2025 | 78FDISNARE, FLEXIBLE | Division of Northern Border Imports (DNBI) | |
| 7/15/2025 | 78FDISNARE, FLEXIBLE | Division of Northern Border Imports (DNBI) | |
| 7/15/2025 | 78FDISNARE, FLEXIBLE | Division of Northern Border Imports (DNBI) | |
| 7/15/2025 | 78FDISNARE, FLEXIBLE | Division of Northern Border Imports (DNBI) | |
| 1/15/2025 | 78FBKNEEDLE, ENDOSCOPIC | 126FAILS STD | Division of Northern Border Imports (DNBI) |
| 8/10/2023 | 78FDISNARE, FLEXIBLE | 78STERILITY | Division of Northern Border Imports (DNBI) |
| 6/27/2019 | 78MQRSTENT, COLONIC, METALIC, EXPANDABLE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Micro-Tech (Nanjing) Co., Ltd.'s FDA import refusal history?
Micro-Tech (Nanjing) Co., Ltd. (FEI: 3004837686) has 15 FDA import refusal record(s) in our database, spanning from 6/27/2019 to 11/20/2025.
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. Micro-Tech (Nanjing) Co., Ltd.'s FEI number is 3004837686.
What types of violations has Micro-Tech (Nanjing) Co., Ltd. received?
Micro-Tech (Nanjing) Co., Ltd. has been cited for 6 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 Micro-Tech (Nanjing) Co., Ltd. come from?
All FDA import refusal data for Micro-Tech (Nanjing) 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.