Zhejiang Kindly Medical Devices Co., Ltd.
⚠️ Moderate Risk
FEI: 3003560965 • Wenzhou, Zhejiang • CHINA
FEI Number
3003560965
Location
Wenzhou, Zhejiang
Country
CHINAAddress
# 758 Binghai Five Rd., Longwan District, Wenzhou, Zhejiang, 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.
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).
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/6/2025 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 5/16/2025 | 80FMFSYRINGE, PISTON | Division of Southeast Imports (DSEI) | |
| 5/15/2025 | 80KZHINTRODUCER, SYRINGE NEEDLE | Division of Southeast Imports (DSEI) | |
| 4/8/2025 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/28/2025 | 81KSTSYSTEM, BLOOD COLLECTION, VACUUM-ASSISTED | Division of West Coast Imports (DWCI) | |
| 3/25/2021 | 80FLKTHERMOMETER, CLINICAL MERCURY | Division of Southeast Imports (DSEI) | |
| 3/19/2018 | 80FLKTHERMOMETER, CLINICAL MERCURY | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Zhejiang Kindly Medical Devices Co., Ltd.'s FDA import refusal history?
Zhejiang Kindly Medical Devices Co., Ltd. (FEI: 3003560965) has 7 FDA import refusal record(s) in our database, spanning from 3/19/2018 to 8/6/2025.
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. Zhejiang Kindly Medical Devices Co., Ltd.'s FEI number is 3003560965.
What types of violations has Zhejiang Kindly Medical Devices Co., Ltd. received?
Zhejiang Kindly 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 Zhejiang Kindly Medical Devices Co., Ltd. come from?
All FDA import refusal data for Zhejiang Kindly 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.