Beijing M&B Electronic Instruments Co., LTD
⚠️ Moderate Risk
FEI: 3006617463 • Beijing, Beijing • CHINA
FEI Number
3006617463
Location
Beijing, Beijing
Country
CHINAAddress
27 Yongwang Rd, Daxing District, Beijing, 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
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).
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.
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/22/2018 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | Division of Southwest Imports (DSWI) | |
| 7/12/2011 | 73CCEANALYZER, GAS, OXYGEN, PARTIAL PRESSURE, BLOOD-PHASE, INDWELLING | 341REGISTERED | Florida District Office (FLA-DO) |
| 1/12/2009 | 74DRTMONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM) | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Beijing M&B Electronic Instruments Co., LTD's FDA import refusal history?
Beijing M&B Electronic Instruments Co., LTD (FEI: 3006617463) has 3 FDA import refusal record(s) in our database, spanning from 1/12/2009 to 10/22/2018.
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 M&B Electronic Instruments Co., LTD's FEI number is 3006617463.
What types of violations has Beijing M&B Electronic Instruments Co., LTD received?
Beijing M&B Electronic Instruments Co., LTD has been cited for 5 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 M&B Electronic Instruments Co., LTD come from?
All FDA import refusal data for Beijing M&B Electronic Instruments Co., LTD 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.