BEIJING KAI DI TAI MEDICAL TECHN
✅ Low Risk
FEI: 3014914389 • Beijing, Beijing • CHINA
FEI Number
3014914389
Location
Beijing, Beijing
Country
CHINAAddress
33 Anding Road, , Beijing, Beijing, 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).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
Refusal History
Frequently Asked Questions
What is BEIJING KAI DI TAI MEDICAL TECHN's FDA import refusal history?
BEIJING KAI DI TAI MEDICAL TECHN (FEI: 3014914389) has 1 FDA import refusal record(s) in our database, spanning from 12/13/2018 to 12/13/2018.
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. BEIJING KAI DI TAI MEDICAL TECHN's FEI number is 3014914389.
What types of violations has BEIJING KAI DI TAI MEDICAL TECHN received?
BEIJING KAI DI TAI MEDICAL TECHN has been cited for 4 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 BEIJING KAI DI TAI MEDICAL TECHN come from?
All FDA import refusal data for BEIJING KAI DI TAI MEDICAL TECHN 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.