Pentax Gmbh
⚠️ Moderate Risk
FEI: 3000228434 • Hamburg, Hamburg • GERMANY
FEI Number
3000228434
Location
Hamburg, Hamburg
Country
GERMANYAddress
Julius-Vosseler-Str. 104, , 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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/30/2004 | 78FEMACCESSORIES, PHOTOGRAPHIC, FOR ENDOSCOPE (EXCLUDE LIGHT SOURCES) | 341REGISTERED | Florida District Office (FLA-DO) |
| 11/30/2004 | 78FEMACCESSORIES, PHOTOGRAPHIC, FOR ENDOSCOPE (EXCLUDE LIGHT SOURCES) | 341REGISTERED | Florida District Office (FLA-DO) |
| 11/30/2004 | 78FEMACCESSORIES, PHOTOGRAPHIC, FOR ENDOSCOPE (EXCLUDE LIGHT SOURCES) | 341REGISTERED | Florida District Office (FLA-DO) |
| 11/30/2004 | 78FEMACCESSORIES, PHOTOGRAPHIC, FOR ENDOSCOPE (EXCLUDE LIGHT SOURCES) | 341REGISTERED | Florida District Office (FLA-DO) |
| 11/30/2004 | 78FEMACCESSORIES, PHOTOGRAPHIC, FOR ENDOSCOPE (EXCLUDE LIGHT SOURCES) | 341REGISTERED | Florida District Office (FLA-DO) |
| 11/30/2004 | 78FEMACCESSORIES, PHOTOGRAPHIC, FOR ENDOSCOPE (EXCLUDE LIGHT SOURCES) | 341REGISTERED | Florida District Office (FLA-DO) |
| 11/30/2004 | 78KOGENDOSCOPE AND/OR ACCESSORIES | 341REGISTERED | Florida District Office (FLA-DO) |
| 11/30/2004 | 78KOGENDOSCOPE AND/OR ACCESSORIES | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Pentax Gmbh's FDA import refusal history?
Pentax Gmbh (FEI: 3000228434) has 8 FDA import refusal record(s) in our database, spanning from 11/30/2004 to 11/30/2004.
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. Pentax Gmbh's FEI number is 3000228434.
What types of violations has Pentax Gmbh received?
Pentax Gmbh 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 Pentax Gmbh come from?
All FDA import refusal data for Pentax Gmbh 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.