Stapes Prostheses made of Nitinol/PTFE
by SPIGGLE & THEIS Medizintechnik GmbH EUDAMED 24 variants
Active
Ref 10740475S
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-04250676721426 | Date30 Sep 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Specification
- Device Name
- Stapes Prostheses made of Nitinol/PTFE
- Model / Reference
- 10740475S
- Primary DI / UDI-DI
- 04250676721426
- Basic UDI-DI
- B-04250676721426
- EMDN Code
- P02010102 Stapedioplastic prostheses
- Device Class
- Class IIb
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000006647
From the manufacturer
Manufacturer's product page: Stapes Prostheses
Other devices from SPIGGLE & THEIS Medizintechnik GmbH
Properties
Other properties (11)
- 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