Adult 3FL
by vBionic sp. z o.o. EUDAMED
Active
Ref ADULT 3FLModel Tolka kosmetyczna proteza ręki
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number5906138350TolkaQP | Date31 Aug 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Tolka kosmetyczna proteza ręki
- Model / Reference
- Tolka kosmetyczna proteza ręki, ADULT 3FL
- Primary DI / UDI-DI
- 05906138350084
- Basic UDI-DI
- 5906138350TolkaQP
- EMDN Code
- Y061809 Transradial prostheses (for amputation under elbow)
- Device Class
- Class I
- Market of Registration
- Poland
Manufacturer details
- EUDAMED SRN
- PL-MF-000056684
Other devices from vBionic sp. z o.o.
Properties
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