Uneo Unique, BK Liner - Replacement
by Otto Bock HealthCare LP 39 variants
Ref 6Y402=L-F-W-1Model 6Y402
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 | Number40644090000000006Y402ZP 04065482036578 | Date8 Sep 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- Withdrawn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
- Model / Reference
- 6Y402, 6Y402=L-F-W-1
- Primary DI / UDI-DI
- 04065482036578
- Basic UDI-DI
- 40644090000000006Y402ZP
- EMDN Code
- Y062409 Transtibial prostheses (for amputation under knee)
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- US-MF-000019567
- Authorised representative
- Ottobock SE & Co. KGaA DE-AR-000016531
Other devices from Otto Bock HealthCare LP
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