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TOUCH® - CMC1 Prosthesis - Offset Neck 15° - 8mm - M
EUDAMEDFDA UDIClass III (EU MDR)
Ref NTO158
Identity
- Trade Name
- TOUCH® - CMC1 Prosthesis - Offset Neck 15° - 8mm - M EUDAMEDTOUCH® CMC 1 FDA UDI
- Generic Name
- Metacarpal prosthesis FDA UDI
- Device Name
- TOUCH CMC1 Prosthesis EUDAMED
- Model / Reference
- NTO158 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640181162635 EUDAMED07640181160051 FDA UDI
- Basic UDI-DI
- 764018116010AV EUDAMED
- PMA Number
- P240020 FDA UDI
- FDA Product Code
- SFA FDA UDI
- EMDN Code
- P090404 HAND PROSTHESES TRAPEZIO-METACARPAL COMPONENTS EUDAMED
- GMDN Term
- Metacarpal prosthesis FDA UDI
Classification
- Device Class
- Class III EUDAMEDFDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
TOUCH® - CMC1 Prosthesis - Offset Neck 15° - 8mm - M by Keri Medical SA — Class III — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 764018116010AV | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Keri Medical SA
- EUDAMED SRN
- CH-MF-000021960
- Authorised Representative
- Keri Medical France FR-AR-000009590
Sources (2)
- EUDAMED b036029d-64ff-4c3d-8ea3-b9233b18e301 61 fields · synced Jul 10, 2026
- FDA UDI adcebed1-25a1-458e-8374-cbcec9583656 33 fields · synced May 30, 2026