Identity
- Trade Name
- CALCANAIL COUVERCLE V3 EUDAMEDCouvercle CALCANAIL V3 FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- TRAYS, LIDS, MATS EUDAMED
- Model / Reference
- 268773 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 03661489687730 EUDAMEDFDA UDI
- Basic UDI-DI
- 3661489PANIERCIAH EUDAMED
- Direct Marketing DI
- 03661489687730 EUDAMED
- FDA Product Code
- HSB FDA UDI
- EMDN Code
- V0499 CLINICAL USE CONTAINERS (NON-IVD) - OTHER EUDAMED
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3020 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
No
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: Instrument transport trolley system
Calcanail Couvercle V3 by Fournitures Hospitalieres Industrie — Class I — 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 | 3661489PANIERCIAH | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Fournitures Hospitalieres Industrie
- EUDAMED SRN
- FR-MF-000000819
Sources (2)
- EUDAMED 53b04f85-f689-402f-943e-b60df67a739f 61 fields · synced Jul 18, 2026
- FDA UDI 2a8c27ba-016f-4400-9579-6dd32d59dac1 32 fields · synced May 29, 2026