FDA Registration
Active
🇩🇪 Germany
BENTLEY INNOMED GMBH
Reg #: 3009128730
·
FEI: 3009128730
·
Expires 2026
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BENTLEY INNOMED GMBH
- Registration Number
- 3009128730
- FEI Number
- 3009128730
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Lotzenaecker 3
- City
- Hechingen Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K211802
Owner / Operator
- Firm Name
- Bentley InnoMed GmbH
- Operator Number
- 10087691
- Address
- Lotzenaecker 3
- City
- Hechingen
- State
- Baden-Wurttemberg
- Postal Code
- 72379
- Country
- DE
US Agent
- Business Name
- Bentley USA Inc.
- Contact Name
- Ben St Jean
- Address
- 222 International Drive, Suite 160
- City
- Portsmouth
- State
- NH
- ZIP
- 03801
- Country
- US
- [email protected]
- Phone
- 603 2055772
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter For Crossing Total Occlusions | PDU | Class 2 | Cardiovascular | No | 2023-03-28 |
Proprietary Names
BeBack crossing catheter
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility