Identity
- Trade Name
- Lid KeriFlex EUDAMEDFDA UDI
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- Tray/lid KeriFlex, rack+lid KeriFuse EUDAMED
- Model / Reference
- 262PR102004 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640181162253 EUDAMEDFDA UDI
- Basic UDI-DI
- 764018116007B8 EUDAMED
- Direct Marketing DI
- 07640181162253 EUDAMED
- FDA Product Code
- LRP FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
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
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Orthopaedic surgical procedure kit, non-medicated, reusable
Lid KeriFlex by Keri Medical SA — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Keri Medical SA
Sources (2)
- FDA UDI e34b6683-8e7f-4934-815d-036e0b13d4ef 32 fields · synced Jul 15, 2026
- EUDAMED 4f7d1fe5-0958-4be7-a110-66c59502e9b8 61 fields · synced Jul 15, 2026