Gm-K8 M
by PATELLA-96 Kereskedelmi és Szolgáltató Korlátolt Felelősségű Társaság
Ref GM-K8 M
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Overview
At GM-K8 M, our cutting-edge device is designed to provide precise and reliable data for medical professionals. This Class I device meets the highest standards of sterilization and compliance, making it an ideal choice for various clinical applications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number599954297GM0939QZ 05999542979934 | Date1 Mar 2022 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Térdortézisek
- Model / Reference
- GM-K8 M
- Primary DI / UDI-DI
- 05999542979934
- Basic UDI-DI
- 599954297GM0939QZ
- EMDN Code
- Y061209 Knee orthoses
- Device Class
- Class I
- EU market of registration
- Hungary
Manufacturer details
- EUDAMED SRN
- HU-MF-000004588
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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