Identity
- Device Name
- FALKO EUDAMED
- Model / Reference
- FK301DV EUDAMEDFK201DV EUDAMED
Identifiers
- Primary DI / UDI-DI
- D121FK201DV0 EUDAMED
- Basic UDI-DI
- ++D121FK301DV79 EUDAMED
- EMDN Code
- Z119099 VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Falko by Tecnomed Italia Srl — 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 | ++D121FK301DV79 | Class I | Active |
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Manufacturer
- Manufacturer
- Tecnomed Italia Srl
- EUDAMED SRN
- IT-MF-000048764
Sources (1)
- EUDAMED ffd57845-4acb-43d1-8e9a-da13004affe2 61 fields · synced Jun 18, 2026