Identity
- Trade Name
- FLUOCART EUDAMED
- Device Name
- FLUOCART EUDAMED
- Model / Reference
- FX-CL EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B475FKCL0 EUDAMED
- Basic UDI-DI
- ++B475FK9Y EUDAMED
- Direct Marketing DI
- +B475FKCL0 EUDAMED
- EMDN Code
- Z119080 VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Fluocart by Fluoptics Sas — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++B475FK9Y | Class I | Active |
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Manufacturer
- Manufacturer
- Fluoptics Sas
- EUDAMED SRN
- FR-MF-000000403
Sources (1)
- EUDAMED dde36be5-c177-427a-afdd-0ac22601389e 61 fields · synced Jul 10, 2026