SHENZHEN ANASONIC BIO-MEDICAL TE
✅ Low Risk
FEI: 3012777191 • Shenzhen • CHINA
FEI Number
3012777191
Location
Shenzhen
Country
CHINAAddress
6f/B Nanfeng Bldg Yungu, Liuxian Ave No 1183 Taoyuan St, Shenzhen, , 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).
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.
Refusal History
Frequently Asked Questions
What is SHENZHEN ANASONIC BIO-MEDICAL TE's FDA import refusal history?
SHENZHEN ANASONIC BIO-MEDICAL TE (FEI: 3012777191) has 1 FDA import refusal record(s) in our database, spanning from 3/31/2020 to 3/31/2020.
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. SHENZHEN ANASONIC BIO-MEDICAL TE's FEI number is 3012777191.
What types of violations has SHENZHEN ANASONIC BIO-MEDICAL TE received?
SHENZHEN ANASONIC BIO-MEDICAL TE has been cited for 2 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 SHENZHEN ANASONIC BIO-MEDICAL TE come from?
All FDA import refusal data for SHENZHEN ANASONIC BIO-MEDICAL TE 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.