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Omniscop FP
EUDAMEDClass IIb (EU MDR)
Ref 74 09 000-1; 74 11 000-1Model ARCO FPRef 74 09 000-1 / 74 11 000-1Model OMNISCOP FP
Identity
- Trade Name
- Omniscop FP EUDAMEDRADIOLOGIA OMNISCOP FP EUDAMED
- Device Name
- OMNISCOP FP EUDAMED
- Model / Reference
- ARCO FP EUDAMED74 09 000-1; 74 11 000-1 EUDAMEDOMNISCOP FP EUDAMED74 09 000-1 / 74 11 000-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055186670594 EUDAMED
- Basic UDI-DI
- 805518667FPVP EUDAMEDB-08055186670594 EUDAMED
- Direct Marketing DI
- 08055186670594 EUDAMED
- EMDN Code
- Z11039017 MOBILE RADIOSCOPIC UNITS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain EUDAMEDItaly 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 — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 805518667FPVP | Class IIb | Active |
| 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 (3)
- EUDAMED 0fb7756d-3e58-472d-8bfe-4344500d19f1 61 fields · synced Oct 6, 2026
- EUDAMED 978b93d0-c751-4f84-a947-76805000ce09 61 fields · synced May 18, 2026
- EUDAMED 0fb7756d-3e58-472d-8bfe-4344500d19f1-1 61 fields · synced Jun 10, 2026