Kra Med
⚠️ Moderate Risk
FEI: 1000500524 • Hamburg, Hamburg • GERMANY
FEI Number
1000500524
Location
Hamburg, Hamburg
Country
GERMANYAddress
Schunemannstieg 2729, , Hamburg, Hamburg, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/1/2001 | 77FWNPROSTHESIS, LARYNX (STENTS AND KEELS) | 237NO PMA | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Kra Med's FDA import refusal history?
Kra Med (FEI: 1000500524) has 1 FDA import refusal record(s) in our database, spanning from 11/1/2001 to 11/1/2001.
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. Kra Med's FEI number is 1000500524.
What types of violations has Kra Med received?
Kra Med has been cited for 1 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 Kra Med come from?
All FDA import refusal data for Kra Med 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.