FDA Registration
Active
🇩🇪 Germany
GPE MedTech Systeme GmbH
Reg #: 3008867836
·
FEI: 3008867836
·
Expires 2026
Products
9
Proprietary Names
1
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- GPE MedTech Systeme GmbH
- Registration Number
- 3008867836
- FEI Number
- 3008867836
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Gewerbestrasse 1
- City
- Dassow Mecklenburg-Western Pomerania
- Country
- DE
Owner / Operator
- Firm Name
- GPE MedTech Systeme GmbH
- Operator Number
- 10094674
- 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
- Melissa Gray
- Address
- 6 Tech Drive
- City
- Andover
- State
- MA
- ZIP
- 01810
- Country
- US
- [email protected]
- Phone
- 978 4473613
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | Class 1 | Anesthesiology | No | 2025-12-16 |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | Class 1 | Anesthesiology | No | 2025-12-16 |
| Ventilator, Continuous, Facility Use | CBK | Class 2 | Anesthesiology | No | 2025-12-16 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2025-12-16 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2025-12-16 |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | Class 2 | General Hospital | No | 2025-12-16 |
| Connector, Airway (Extension) | BZA | Class 1 | Anesthesiology | No | 2025-12-16 |
| Drain, Tee (Water Trap) | BYH | Class 1 | Anesthesiology | No | 2025-12-16 |
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2025-12-16 |
Proprietary Names
2M19063 Angular porcelain bush
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)