Resmed (Beijing Medical Device
⚠️ Moderate Risk
FEI: 3011118844 • Beijing • CHINA
FEI Number
3011118844
Location
Beijing
Country
CHINAAddress
Rm 2505 25/F Bldg B Landgent Cen, , Beijing, , 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
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 Resmed (Beijing Medical Device's FDA import refusal history?
Resmed (Beijing Medical Device (FEI: 3011118844) has 1 FDA import refusal record(s) in our database, spanning from 11/26/2024 to 11/26/2024.
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. Resmed (Beijing Medical Device's FEI number is 3011118844.
What types of violations has Resmed (Beijing Medical Device received?
Resmed (Beijing Medical Device 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 Resmed (Beijing Medical Device come from?
All FDA import refusal data for Resmed (Beijing Medical Device 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.