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KeriFlex® - PIP Finger Joint Implant - PIP 1
EUDAMEDFDA UDIClass III (EU MDR)
Ref 210-P20001
Identity
- Trade Name
- KeriFlex® - PIP Finger Joint Implant - PIP 1 EUDAMEDKeriFlex FDA UDI
- Generic Name
- Proximal interphalangeal joint prosthesis, one-piece FDA UDI
- Device Name
- KeriFlex - MCP and PIP Finger Joint Implants EUDAMED
- Model / Reference
- 210-P20001 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640181160655 EUDAMEDFDA UDI
- Basic UDI-DI
- 764018116011AX EUDAMED
- 510(k) Number
- K211385 FDA UDI
- FDA Product Code
- KYJ FDA UDI
- EMDN Code
- P090403 HAND PROSTHESES INTERPHALANGE COMPONENTS EUDAMED
- GMDN Term
- Proximal interphalangeal joint prosthesis, one-piece FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3230 FDA 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
KeriFlex® - PIP Finger Joint Implant - PIP 1 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 | 764018116011AX | 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 f7aae742-3ecd-4c65-b0d5-7a6bb3acf45a 61 fields · synced Jul 9, 2026
- FDA UDI 487f8c84-eb5c-4d16-881e-354bd28476f3 33 fields · synced May 29, 2026