KLS Martin GmbH & Co. KG
⚠️ Moderate Risk
FEI: 1000614294 • Freiburg Im Breisgau, Baden-Wurttemberg • GERMANY
FEI Number
1000614294
Location
Freiburg Im Breisgau, Baden-Wurttemberg
Country
GERMANYAddress
Am Flughafen 18, , Freiburg Im Breisgau, Baden-Wurttemberg, Germany
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
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).
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 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 |
|---|---|---|---|
| 8/3/2018 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Division of West Coast Imports (DWCI) | |
| 1/23/2017 | 79GCJLAPAROSCOPE, GENERAL & PLASTIC SURGERY | 237NO PMA | Division of Southwest Imports (DSWI) |
| 1/23/2017 | 79GCJLAPAROSCOPE, GENERAL & PLASTIC SURGERY | 237NO PMA | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is KLS Martin GmbH & Co. KG's FDA import refusal history?
KLS Martin GmbH & Co. KG (FEI: 1000614294) has 3 FDA import refusal record(s) in our database, spanning from 1/23/2017 to 8/3/2018.
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. KLS Martin GmbH & Co. KG's FEI number is 1000614294.
What types of violations has KLS Martin GmbH & Co. KG received?
KLS Martin GmbH & Co. KG 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 KLS Martin GmbH & Co. KG come from?
All FDA import refusal data for KLS Martin GmbH & Co. KG 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.