Identity
- Trade Name
- Centering guide EUDAMEDTouch CMC 1 - K-Wire Centering Guide FDA UDI
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- Guide EUDAMED
- Model / Reference
- 112-A28000 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640181160921 EUDAMEDFDA UDI
- Basic UDI-DI
- 764018116017BB EUDAMED
- PMA Number
- P240020 FDA UDI
- FDA Product Code
- SFA FDA UDI
- EMDN Code
- L091104 ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass III FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic implant impactor, reusable
Centering guide by Keri Medical SA — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 764018116017BB | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 67801b35-db12-46ce-9c2e-ffcabf685573 61 fields · synced Jun 19, 2026
- FDA UDI d292272b-8908-43ee-bb50-dabd61dadeb2 33 fields · synced May 30, 2026