TOUCH® - CMC1 Prosthesis - Straight Neck 0° - 8mm - M
by Keri Medical SA Switzerland EUDAMEDGUDID
Ref NTO08
Product code SFAEMDN P090404
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number28620157857-03 | Date20 Mar 2026 | StatusActive |
| United States | GUDID listing GUDID | Number07640181162604 | Date18 Jul 2025 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Certificates
- 28620157857-03 Issued
Technical documentation EU MDR
- Notified body
- Intertek Medical Notified Body AB 2862
- Issued
- 20 Mar 2026
- Expires
- 15 Feb 2028
Specification
- Trade Name
- TOUCH® - CMC1 Prosthesis - Straight Neck 0° - 8mm - M EUDAMEDTouch Cmc 1 EUDAMEDTouch® Cmc 1 GUDID
- Generic Name
- Metacarpal prosthesis
- Device Name
- TOUCH CMC1 Prosthesis
- Model / Reference
- NTO08
- Primary DI / UDI-DI
- 07640181162604, 07640181160020
- Basic UDI-DI
- 764018116010AV
- PMA Number
- FDA Product Code
- SFA
- EMDN Code
- P090404 Hand prostheses trapezio-metacarpal components
- GMDN Term
- Metacarpal prosthesis
- Device Class
- Class III
- Market of Registration
- France
- Commercial Distribution
- In Commercial Distribution
- MRI Safety
- MR Conditional
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Contains Latex | No | Yes |
Manufacturer details
- EUDAMED SRN
- CH-MF-000021960
- Authorised representative
- Keri Medical France FR-AR-000009590
Other devices from Keri Medical SA
Properties & raw data
Show properties, registry sources and raw records
Other properties (17)
- Reusable: 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
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No
Sources (3)
- EUDAMED 9880215c-e0ed-4c27-9845-ace4d89215ad
- FDA UDI 3b4f8b72-2d63-41ee-bd0d-24e77379a2e9
- EUDAMED 07640181160020|764018116010AV