Mediatronic S.A.
⚠️ Moderate Risk
FEI: 3004152702 • Les Acacias, Geneva • SWITZERLAND
FEI Number
3004152702
Location
Les Acacias, Geneva
Country
SWITZERLANDAddress
route des Jeunes 5C, , Les Acacias, Geneva, Switzerland
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).
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).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/23/2011 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 9/13/2010 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 6/14/2004 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 1/31/2002 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 1/31/2002 | 66VNJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Mediatronic S.A.'s FDA import refusal history?
Mediatronic S.A. (FEI: 3004152702) has 5 FDA import refusal record(s) in our database, spanning from 1/31/2002 to 2/23/2011.
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. Mediatronic S.A.'s FEI number is 3004152702.
What types of violations has Mediatronic S.A. received?
Mediatronic S.A. 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 Mediatronic S.A. come from?
All FDA import refusal data for Mediatronic S.A. 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.