FDA Registration
Active
🇩🇪 Germany
ERBECRYO 2 Cryosurgical Unit and Accessories
Reg #: 9610614
·
FEI: 3002806920
·
Expires 2025
Products
1
Proprietary Names
13
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ERBE ELEKTROMEDIZIN GMBH
- Registration Number
- 9610614
- FEI Number
- 3002806920
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- WALDHOERNLESTRASSE 17
- City
- TUEBINGEN Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K151041
Owner / Operator
- Firm Name
- ERBE ELEKTROMEDIZIN GMBH
- Operator Number
- 8010173
- Address
- WALDHOERNLESTRASSE 17, --
- City
- TUEBINGEN
- State
- DE-NOTA
- Postal Code
- 72072
- Country
- DE
US Agent
- Business Name
- ERBE USA, INC.
- Contact Name
- JOHN TARTAL
- Address
- 2225 NORTHWEST PKWY.
- City
- MARIETTA
- State
- GA
- ZIP
- 30067
- Country
- US
- [email protected]
- Phone
- 770 9554400 ext. 133
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Unit, Cryosurgical, Accessories | GEH | Class 2 | General, Plastic Surgery | No | 2015-06-26 |
Proprietary Names
ERBECRYO 2 Cryosurgical Unit and Accessories
Flexible gas hose
Cryo probe 2
ERBECRYO 2 1-pedal footswitch
Switching valve w/ 2 Adapt. E
Wire basket
ERBECRYO 2 Cart
ERBECRYO 2
Switching valve w/ 2 Adapt. H
Exhaust gas hose; L. 10m open end
Extension cable (for ERBECRYO 2 footswitch)
Gas cylinder connector CO2/D
Exhaust gas hose; L. 5m open end
Establishment Types
Manufacture Medical Device