Beijing Medical Radiology Factory
⚠️ Moderate Risk
FEI: 3008604118 • Beijingshi, Beijingshi • CHINA
FEI Number
3008604118
Location
Beijingshi, Beijingshi
Country
CHINAAddress
Lang Jia Yuan 6 Jianwaidajie, , Beijingshi, Beijingshi, 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
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).
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.
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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.
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/3/2014 | 79OHVFOCUSED ULTRASOUND FOR TISSUE HEAT OR MECHANICAL CELLULAR DISRUPTION | Los Angeles District Office (LOS-DO) | |
| 4/23/2014 | 79OYWFOR THE REMOVAL OF FAT THROUGH LASER LIPOLYSIS | Cincinnati District Office (CIN-DO) | |
| 11/27/2012 | 79MYHSYSTEM, NON-COHERENT LIGHT, PHOTODYNAMIC THERAPY | Los Angeles District Office (LOS-DO) | |
| 12/17/2010 | 89HPHDIATHERMY, MICROWAVE, FOR USE OTHER THAN APPLYING THERAPEUTIC DEEP HEAT | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Beijing Medical Radiology Factory's FDA import refusal history?
Beijing Medical Radiology Factory (FEI: 3008604118) has 4 FDA import refusal record(s) in our database, spanning from 12/17/2010 to 6/3/2014.
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 Medical Radiology Factory's FEI number is 3008604118.
What types of violations has Beijing Medical Radiology Factory received?
Beijing Medical Radiology Factory has been cited for 9 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 Medical Radiology Factory come from?
All FDA import refusal data for Beijing Medical Radiology Factory 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.