Zhuhai Linte Medical Instrument Co., Ltd.
⚠️ Moderate Risk
FEI: 3016170326 • Zhuhai, Guangdong • CHINA
FEI Number
3016170326
Location
Zhuhai, Guangdong
Country
CHINAAddress
4th Floor, Building 1, No.66, Yongda Road, Hongqi Town, Jinwan District, , Zhuhai, Guangdong, 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
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).
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.
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 |
|---|---|---|---|
| 7/7/2022 | 75LXGEQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 6/18/2020 | 74OCHOXIMETER, INFRARED, SPORTING, AVIATION | Division of Southeast Imports (DSEI) | |
| 6/10/2020 | 73DQAOXIMETER | 508NO 510(K) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Zhuhai Linte Medical Instrument Co., Ltd.'s FDA import refusal history?
Zhuhai Linte Medical Instrument Co., Ltd. (FEI: 3016170326) has 3 FDA import refusal record(s) in our database, spanning from 6/10/2020 to 7/7/2022.
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. Zhuhai Linte Medical Instrument Co., Ltd.'s FEI number is 3016170326.
What types of violations has Zhuhai Linte Medical Instrument Co., Ltd. received?
Zhuhai Linte Medical Instrument Co., Ltd. has been cited for 3 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 Zhuhai Linte Medical Instrument Co., Ltd. come from?
All FDA import refusal data for Zhuhai Linte Medical Instrument 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.