Gyne
by Fysiotech OÜ Estonia EUDAMED
Ref 20202Model Universal X1
EMDN V080603
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number4745010245202029B | Date17 Aug 2023 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Gyne
- Model / Reference
- Universal X1, 20202
- Primary DI / UDI-DI
- 04745010245053
- Basic UDI-DI
- 4745010245202029B
- Direct Marketing DI
- 04745010245053
- EMDN Code
- V080603 Treatment, diagnosis and monitoring medical beds
- Device Class
- Class I
- Market of Registration
- Estonia
Manufacturer details
- EUDAMED SRN
- EE-MF-000007651
Other devices from Fysiotech OÜ
Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 3d1382f5-414e-4e88-848c-1eeebdd4ed20