FDA Registration
Active
🇩🇪 Germany
GPE MedTech Systeme GmbH
Reg #: 3008867836
·
FEI: 3008867836
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GPE MedTech Systeme GmbH
- Registration Number
- 3008867836
- FEI Number
- 3008867836
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Gewerbestrasse 1
- City
- Dassow Mecklenburg-Western Pomerania
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K100941
Owner / Operator
- Firm Name
- GPE-Systeme
- Operator Number
- 10047011
- Address
- Gewerbestrasse 1
- City
- Dassow
- State
- Mecklenburg-Western Pomerania
- Postal Code
- 23942
- Country
- DE
- Correspondent
- Kai Bannicke
US Agent
- Business Name
- DRAEGER MEDICAL SYSTEMS, INC.
- Contact Name
- John Ferros
- Address
- 6 TECH DRIVE
- City
- Andover
- State
- MA
- ZIP
- 01810
- Country
- US
- [email protected]
- Phone
- 978 4828515
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2023-11-28 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)