Prosthetic joints
by Nobel China Limited 11 variants
Ref PN65, A811-CH, PH15, 4A22, 3A17C, PN930, SC811, 6A7, 3A16C, PN920, SC817
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 | Number489714953PJ4C | Date5 Nov 2025 | 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- Withdrawn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
- Artificial Limb Components
- Model / Reference
- PN65, A811-CH, PH15, 4A22, 3A17C, PN930, SC811, 6A7, 3A16C, PN920, SC817
- Primary DI / UDI-DI
- 04897149530132, 04897149530163, 04897149530156, 04897149530149, 04897149530194, 04897149530095, 04897149530019, 04897149530118, 04897149530187, 04897149530064, 04897149530224
- Basic UDI-DI
- 489714953PJ4C
- EMDN Code
- Y062499 Lower extremity prostheses - other
- Device Class
- Class I
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- CN-MF-000011924
- Authorised representative
- MedPath GmbH DE-AR-000000087
Other devices from Nobel China Limited
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