FDA Registration
Active
🇩🇪 Germany
Micro Camera
Reg #: 9611112
·
FEI: 3008782585
·
Expires 2025
Products
5
Proprietary Names
2
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- HEBUMEDICAL GMBH
- Registration Number
- 9611112
- FEI Number
- 3008782585
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- BADSTRASSE 8
- City
- TUTTLINGEN Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K974493
Owner / Operator
- Firm Name
- HEBUMEDICAL GMBH
- Operator Number
- 8010320
- Address
- BADSTRASSE 8, --
- City
- TUTTLINGEN
- State
- DE-NOTA
- Postal Code
- 78532
- Country
- DE
- Correspondent
- THOMAS - BUTSCH
US Agent
- Business Name
- BUSINESS SUPPORT INTERNATIONAL
- Contact Name
- Randolph Scherp
- Address
- 1350 Avenue Of The Americas FL 2
- City
- New York
- State
- NY
- ZIP
- 10019
- Country
- US
- [email protected]
- Phone
- 212 3318358
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Colonoscope And Accessories, Flexible/Rigid | FDF | Class 2 | Gastroenterology, Urology | No | 2025-06-17 |
| Duodenoscope And Accessories, Flexible/Rigid | FDT | Class 2 | Gastroenterology, Urology | No | 2025-06-17 |
| Accessories, Photographic, For Endoscope (Exclude Light Sources) | FEM | Class 1 | Gastroenterology, Urology | No | 2025-06-17 |
| Gastroscope And Accessories, Flexible/Rigid | FDS | Class 2 | Gastroenterology, Urology | No | 2025-06-17 |
| Sigmoidoscope And Accessories, Flexible/Rigid | FAM | Class 2 | Gastroenterology, Urology | No | 2025-06-17 |
Proprietary Names
Micro Camera
Micro Camera Cable
Establishment Types
Repack or Relabel Medical Device