FDA Registration
Active
🇩🇪 Germany
Navigated 6mm up angled Curette
Reg #: 9611112
·
FEI: 3008782585
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
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
- K212756
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 |
|---|---|---|---|---|---|
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2022-05-23 |
Proprietary Names
Navigated 6mm up angled Curette
Navigated 6mm angled ring Curette
Navigated 4mm down biting Curette
Navigated 4mm up angled Curette
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)