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Radiologia Omniscop Fp
EUDAMEDClass IIb (EU MDR)
Ref 74 09 000-2 / 74 11 000-2Model OMNISCOP FPRef 74 09 000-2; 74 11 000-2Model ARCO FP
Identity
- Trade Name
- RADIOLOGIA OMNISCOP FP EUDAMEDOmniscop FP EUDAMED
- Device Name
- OMNISCOP FP EUDAMED
- Model / Reference
- OMNISCOP FP EUDAMED74 09 000-2 / 74 11 000-2 EUDAMEDARCO FP EUDAMED74 09 000-2; 74 11 000-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055186670600 EUDAMED
- Basic UDI-DI
- B-08055186670600 EUDAMED805518667FPVP EUDAMED
- Direct Marketing DI
- 08055186670600 EUDAMED
- EMDN Code
- Z11039017 MOBILE RADIOSCOPIC UNITS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMEDSpain 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
Radiologia Omniscop Fp by A.T.S. Applicazione Tecnologie Speciali s.r.l. — Class IIb — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08055186670600 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08055186670600 | 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 999e44d0-db9e-4b88-8fb0-2fdec843e949 61 fields · synced Oct 7, 2026
- EUDAMED 12f01daa-8c13-4e21-93e1-33396a0bf33f 61 fields · synced May 17, 2026
- EUDAMED 12f01daa-8c13-4e21-93e1-33396a0bf33f-1 61 fields · synced Jun 10, 2026