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Omniscop FP
EUDAMEDClass IIb (EU MDR)
Ref 74 10 000-3; 74 12 000-3; 74 14 000; 74 15 000Model ARCO FP
Identity
- Trade Name
- Omniscop FP EUDAMED
- Model / Reference
- ARCO FP EUDAMED74 10 000-3; 74 12 000-3; 74 14 000; 74 15 000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055186670792 EUDAMED
- Basic UDI-DI
- 805518667FPVP EUDAMED
- Direct Marketing DI
- 08055186670792 EUDAMED
- EMDN Code
- Z11039017 MOBILE RADIOSCOPIC UNITS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain 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
Omniscop FP by A.T.S. Applicazione Tecnologie Speciali s.r.l. — Class IIb — 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 | 805518667FPVP | Class IIb | Active |
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Manufacturer
- Manufacturer
- A.T.S. Applicazione Tecnologie Speciali s.r.l.
- EUDAMED SRN
- IT-MF-000010734
Sources (2)
- EUDAMED 7bb45661-665c-421c-922d-7d53650f117a 61 fields · synced Oct 6, 2026
- EUDAMED 7bb45661-665c-421c-922d-7d53650f117a-1 61 fields · synced Jun 10, 2026