Gymna Acure 250
by GymnaUniphy N.V. Belgium EUDAMED
Ref 370300Model Devices for electrolysis and dry needling EMDN Z120601
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number5425022610500SB | Date17 Dec 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- 2257802CE01 Supplemented
Quality management system EU MDR
- Notified body
- Notified body 0344
- Issued
- 22 May 2025
- Expires
- 1 Oct 2028
- Reason
- Add device or group
Specification
- Model / Reference
- Devices for electrolysis and dry needling, 370300
- Primary DI / UDI-DI
- 05425022614496
- Basic UDI-DI
- 5425022610500SB
- Direct Marketing DI
- 05425022614496
- EMDN Code
- Z120601 Electrotherapy equipment (included tens)
- Device Class
- Class IIa
- Market of Registration
- Belgium
Manufacturer details
- EUDAMED SRN
- BE-MF-000001786
Other devices from GymnaUniphy N.V.
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 c4807405-578b-4662-b294-f492934593ca