Touch® Cmc 1 STO2
Part of a family of 42 devices: see the family page
Ref STO2
Touch® Cmc 1 STO2 is a Class III device made by Keri Medical SA, registered in EUDAMED on 16 Oct 2023 (Basic UDI-DI 764018116010AV) with CE/MDR certificate 28620157857-03 valid until 15 Feb 2028, approved under FDA PMA P240020 on 10 Jul 2025 and listed in FDA GUDID since 18 Jul 2025 (UDI-DI 07640181160136), active as of 23 Oct 2026.
Active
CE MDR PMA
Valid until
15 Feb 2028
FDA recalls
None found
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number28620157857-03 | Date20 Mar 2026 | StatusActive |
| United States | GUDID listing GUDID | Number07640181160136 | Date18 Jul 2025 | StatusListed |
| United States | FDA PMAAPPR GUDID | NumberP240020 | Date10 Jul 2025 | StatusActive |
Official records
- EUDAMED public site 764018116010AV
- AccessGUDID record 07640181160136
- FDA PMA database P240020
Across registries
- EUDAMED Basic UDI-DI 764018116010AV registered 16 Oct 2023 Active
- FDA PMA P240020 decided 10 Jul 2025 Active
- FDA GUDID UDI-DI 07640181160136 listed 18 Jul 2025 Listed
Certificates
- 28620157857-03 Active
Technical documentation EU MDR
- Certifier
- Intertek Medical Notified Body AB 2862
- Issued
- 20 Mar 2026
- Expires
- 15 Feb 2028
Timeline
- Registered EUDAMED 764018116010AV
- Approved FDA PMA P240020
- Listed FDA GUDID 07640181160136
- Certificate issued EUDAMED 28620157857-03
- Certificate expires EUDAMED 28620157857-03
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Touch Cmc 1 EUDAMEDTouch® Cmc 1 GUDID
- Generic name
- Metacarpal prosthesis
- Device name
- TOUCH CMC1 Prosthesis
- Model / reference
- STO2
- Primary DI / UDI-DI
- 07640181160136
- 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
- EU registration type
- Standard device
- EU market of registration
- France
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
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