Suzhou Ahno Medical Devices Co., Ltd.
✅ Low Risk
FEI: 3014315669 • Suzhou, Jiangsu • CHINA
FEI Number
3014315669
Location
Suzhou, Jiangsu
Country
CHINAAddress
No. 8 Baoda Road, Room B204, SIP, Suzhou, Jiangsu, China
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/20/2018 | 86HRKTABLE, INSTRUMENT, MANUAL, OPHTHALMIC | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Suzhou Ahno Medical Devices Co., Ltd.'s FDA import refusal history?
Suzhou Ahno Medical Devices Co., Ltd. (FEI: 3014315669) has 1 FDA import refusal record(s) in our database, spanning from 9/20/2018 to 9/20/2018.
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. Suzhou Ahno Medical Devices Co., Ltd.'s FEI number is 3014315669.
What types of violations has Suzhou Ahno Medical Devices Co., Ltd. received?
Suzhou Ahno Medical Devices Co., Ltd. has been cited for 1 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 Suzhou Ahno Medical Devices Co., Ltd. come from?
All FDA import refusal data for Suzhou Ahno 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.