Baholzer Endoskopie Systeme
⚠️ Moderate Risk
FEI: 3003943144 • Freiburg im Breisgau, Baden-Wurttemberg • GERMANY
FEI Number
3003943144
Location
Freiburg im Breisgau, Baden-Wurttemberg
Country
GERMANYAddress
Tullastr. 87a, , 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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/2/2003 | 80MQTPUMP, DRUG ADMINISTRATION, CLOSED LOOP | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 7/2/2003 | 80LDQDEVICE, GENERAL MEDICAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 7/2/2003 | 77KCJAPPLICATOR, ENT | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 7/2/2003 | 79JOSELECTRODE, ELECTROSURGICAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 7/2/2003 | 77KTETROCAR, ENT | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 7/2/2003 | 79GEACANNULA, SURGICAL, GENERAL & PLASTIC SURGERY | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 7/2/2003 | 79HTDFORCEPS | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 7/2/2003 | 80LDQDEVICE, GENERAL MEDICAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 7/2/2003 | 79EMFKNIFE, SURGICAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 7/2/2003 | 80LDQDEVICE, GENERAL MEDICAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Baholzer Endoskopie Systeme's FDA import refusal history?
Baholzer Endoskopie Systeme (FEI: 3003943144) has 10 FDA import refusal record(s) in our database, spanning from 7/2/2003 to 7/2/2003.
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. Baholzer Endoskopie Systeme's FEI number is 3003943144.
What types of violations has Baholzer Endoskopie Systeme received?
Baholzer Endoskopie Systeme 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 Baholzer Endoskopie Systeme come from?
All FDA import refusal data for Baholzer Endoskopie Systeme 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.