Memometal Technologies
⚠️ Moderate Risk
FEI: 3004082045 • Bruz, Ille Et Vilaine • FRANCE
FEI Number
3004082045
Location
Bruz, Ille Et Vilaine
Country
FRANCEAddress
rue Blaise Pascal, , Bruz, Ille Et Vilaine, France
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).
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).
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 |
|---|---|---|---|
| 10/13/2010 | 87HWEINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 10/13/2010 | 87HWEINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/28/2008 | 87JDRSTAPLE, FIXATION, BONE | New Orleans District Office (NOL-DO) | |
| 1/28/2008 | 87NCOIMPLANT, CARTILAGE, FOR ARTICULAR CARTILAGE REPAIR | New Orleans District Office (NOL-DO) | |
| 1/28/2008 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Memometal Technologies's FDA import refusal history?
Memometal Technologies (FEI: 3004082045) has 5 FDA import refusal record(s) in our database, spanning from 1/28/2008 to 10/13/2010.
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. Memometal Technologies's FEI number is 3004082045.
What types of violations has Memometal Technologies received?
Memometal Technologies has been cited for 3 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 Memometal Technologies come from?
All FDA import refusal data for Memometal Technologies 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.