Zhejiang Longmed Medical Technology Co., Ltd.
⚠️ High Risk
FEI: 3015456954 • Huzhou, Zhejiang • CHINA
FEI Number
3015456954
Location
Huzhou, Zhejiang
Country
CHINAAddress
Building 8, No. 277 Shuangshan Road, Fuxi Street, Deqing, Huzhou, Zhejiang, 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
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 |
|---|---|---|---|
| 10/1/2025 | 80GCXAPPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 10/1/2025 | 80GCXAPPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 10/1/2025 | 80GCXAPPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED | 508NO 510(K) | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Zhejiang Longmed Medical Technology Co., Ltd.'s FDA import refusal history?
Zhejiang Longmed Medical Technology Co., Ltd. (FEI: 3015456954) has 3 FDA import refusal record(s) in our database, spanning from 10/1/2025 to 10/1/2025.
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 Longmed Medical Technology Co., Ltd.'s FEI number is 3015456954.
What types of violations has Zhejiang Longmed Medical Technology Co., Ltd. received?
Zhejiang Longmed Medical Technology 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 Zhejiang Longmed Medical Technology Co., Ltd. come from?
All FDA import refusal data for Zhejiang Longmed Medical Technology 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.