GENU-HiT SUPREME
Ref 07181
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number04029925Y061209V5 | Date16 Oct 2026 | 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- Withdrawn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
- Trade Name
- GENU-HiT SUPREMEGENU-HiT SUPREME Deko-GENU-HiT SUPREME OR
- Device Name
- Kasseler Patellarsehnenbandage
- Model / Reference
- 07181
- Primary DI / UDI-DI
- 04029925229415, 04029925262726, 04029925241189, 04029925241158, 04029925263136, 04029925262771, 04029925263105, 04029925263143, 04029925229453, 04029925241134, 04029925229460, 04029925247068, 04029925241196, 04029925247051, 04029925263112, 04029925247082, 04029925262733, 04029925229446, 04029925229422, 04029925247020, 04029925262757, 04029925263099, 04029925263129, 04029925254141, 04029925241141, 04029925229408, 04029925263082, 04029925247075, 04029925229439, 04029925262740, 04029925241165, 04029925247037, 04029925262764, 04029925247044, 04029925241172, 04029925262788
- Basic UDI-DI
- 04029925Y061209V5
- EMDN Code
- Y061209 Knee orthoses
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000006346
Other devices from SPORLASTIC GMBH & Co.KG
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