FDA Registration
Active
🇩🇪 Germany
SCHOELLY FIBEROPTIC, GMBH
Reg #: 8043903
·
FEI: 3002808088
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SCHOELLY FIBEROPTIC, GMBH
- Registration Number
- 8043903
- FEI Number
- 3002808088
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- ROBERT-BOSCH-STR. 1-3
- City
- DENZLINGEN Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K191043
Owner / Operator
- Firm Name
- SCHOELLY FIBEROPTIC, GMBH
- Operator Number
- 9004385
- Address
- ROBERT-BOSCH-STR. 1-3, --
- City
- DENZLINGEN
- State
- DE-NOTA
- Postal Code
- 79211
- Country
- DE
- Correspondent
- GERHARD - HERBSTRITT
US Agent
- Business Name
- SCHOELLY USA Inc.
- Contact Name
- James Bonneville
- Address
- 360 Church St., Suite 130
- City
- Northborough
- State
- MA
- ZIP
- 01532
- Country
- US
- [email protected]
- Phone
- 508 9268855
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2019-09-02 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)