UL bundle kit Sensor/Variplus Speed Hand
by Otto Bock Healthcare Products GmbH 12 variants
Ref 70UL39=9-L8-1/4Model 70UL39
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 | Number40644110000000070UL39TT 04064411014939 | Date21 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- Withdrawn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
- Model / Reference
- 70UL39, 70UL39=9-L8-1/4
- Primary DI / UDI-DI
- 04064411014939
- Basic UDI-DI
- 40644110000000070UL39TT
- EMDN Code
- Y061899 Upper extremity prostheses - other
- Device Class
- Class I
- EU market of registration
- Germany
- Medical Purpose
- Kit for fitting UL user with Speed Hand, electrodes, battery and accessories
Manufacturer details
- EUDAMED SRN
- AT-PR-000004582
Other devices from Otto Bock Healthcare Products GmbH
Properties
Other properties (5)
- Sterile: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Endocrine Disruptor: No