Genu Plus
by Easytech S.r.l. Italy EUDAMED
Ref 80000580Model Isocinetica
EMDN Z120603
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberITH 1343914 1 | Date6 Oct 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- ITH 1343914 1 Amended
Quality management system EU MDR
- Notified body
- TUV Rheinland Italia SRL 1936
- Issued
- 6 Oct 2025
- Expires
- 19 Jul 2027
- Reason
- Other
Specification
- Model / Reference
- Isocinetica, 80000580
- Primary DI / UDI-DI
- 08059300920039
- Basic UDI-DI
- 805930092200C8
- Direct Marketing DI
- 08059300920039
- EMDN Code
- Z120603 Passive rehabilitative gymnastics equipment
- Device Class
- Class IIb
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000017907
Other devices from Easytech S.r.l.
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- 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
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED fa742f1c-94cd-45b6-af6a-e8dc8891d3ce