Xtreme X60 4-Bar Hydraulic Knee Joint
by Teh Lin Prosthetic & Orthopaedic lnc 2 variants
Ref C-XTR-X60R
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 | Number47198834600159M 04719883460394 | Date19 Jun 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- Withdrawn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
- Device Name
- Xtreme X60 4-Bar Hydraulic Knee Joint
- Model / Reference
- C-XTR-X60R
- Primary DI / UDI-DI
- 04719883460394
- Basic UDI-DI
- 47198834600159M
- EMDN Code
- Y062415 Transfemoral prostheses (for amputation above knee)
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- TW-MF-000012180
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
Other devices from Teh Lin Prosthetic & Orthopaedic lnc
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