CHENGDU CRYO-PUSH MEDICAL TECHNO
✅ Low Risk
FEI: 3013373037 • Chengdu • CHINA
FEI Number
3013373037
Location
Chengdu
Country
CHINAAddress
188 Kexing Road West, W, , Chengdu, , 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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/20/2020 | 89IRTPAD, HEATING, POWERED | 341REGISTERED | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is CHENGDU CRYO-PUSH MEDICAL TECHNO's FDA import refusal history?
CHENGDU CRYO-PUSH MEDICAL TECHNO (FEI: 3013373037) has 1 FDA import refusal record(s) in our database, spanning from 11/20/2020 to 11/20/2020.
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. CHENGDU CRYO-PUSH MEDICAL TECHNO's FEI number is 3013373037.
What types of violations has CHENGDU CRYO-PUSH MEDICAL TECHNO received?
CHENGDU CRYO-PUSH MEDICAL TECHNO 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 CHENGDU CRYO-PUSH MEDICAL TECHNO come from?
All FDA import refusal data for CHENGDU CRYO-PUSH MEDICAL TECHNO 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.