Uneo, TT
by Otto Bock HealthCare LP 29 variants
Ref 6Y522=190Model 6Y522
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number40644090000000006Y52225 04064409255047 | Date30 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- Withdrawn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
- Device name
- Uneo Pure / Uneo Skinguard
- Model / reference
- 6Y522, 6Y522=190
- Primary DI / UDI-DI
- 04064409255047
- Basic UDI-DI
- 40644090000000006Y52225
- EMDN code
- Y062409 Transtibial prostheses (for amputation under knee)
- Device class
- Class I
- EU registration type
- Standard device
- 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 (14)
- Supplied sterile: No
- Sterilise before use: No
- Implantable: No
- Reusable: No
- Contains latex: No
- Reprocessed single-use device: No
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
- Incorporates a substance derived from human blood or plasma: No
- Contains human tissues or cells: No
- Contains animal tissues or cells: No
- Contains endocrine-disrupting substances: No
- Administering medicine: No
- Measuring function: No
- Incorporates a medicinal substance: No