Ottobock System Hand-passive
by Ottobock SE & Co. KGaA Germany EUDAMED
Ref 8K19=L7 1/4Model 8K19 EMDN Y061809
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number403276700000000008K19X2 | Date7 Oct 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- 8K19, 8K19=L7 1/4
- Primary DI / UDI-DI
- 04032767213436
- Basic UDI-DI
- 403276700000000008K19X2
- EMDN Code
- Y061809 Transradial prostheses (for amputation under elbow)
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000010487
Other devices from Ottobock SE & Co. KGaA
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 04032767213436|403276700000000008K19X2