FDA Registration
Active
🇩🇪 Germany
RayPilot System Cable
Reg #: 3009039068
·
FEI: 3009039068
·
Expires 2025
Products
1
Proprietary Names
12
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HA2 MEDIZINTECHNIK GMBH
- Registration Number
- 3009039068
- FEI Number
- 3009039068
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Am Bahndamm 11
- City
- Halberstadt Saxony-Anhalt
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K203722
Owner / Operator
- Firm Name
- HA2 Medizintechnik GmbH
- Operator Number
- 10042677
- Address
- Am Bahndamm 11
- City
- Halberstadt
- State
- Saxony-Anhalt
- Postal Code
- 38820
- Country
- DE
- Correspondent
- Regina Koelzsch
US Agent
- Business Name
- MEDAGENT Inc.
- Contact Name
- Franz Menean
- Address
- 264 Lafayette Rd Ste 7
- City
- Portsmouth
- State
- NH
- ZIP
- 03801
- Country
- US
- [email protected]
- Phone
- 603 5702039
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | Class 2 | Radiology | No | 2025-03-25 |
Proprietary Names
RayPilot System Cable
RayPilot Transmitter Cable
RayPilot Matching Network
RayPilot Quality Control kit
RayPilot HypoCath
RayPilot Power box
RayPilot Extension plate
RayPilot Software
RayPilot ViewCath
RayPilot Receiver
RayPilot Transmitter tester
RayPilot Table displacement meter
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)