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Radiologia Omniscop Fp-S
EUDAMEDClass IIb (EU MDR)
Ref 95 02 000 / 95 04 000 / 95 07 000 / 95 09 000Model OMNISCOP FP-SRef 95 02 000; 95 04 000; 95 07 000; 95 09 000; 95 05 000Model ARCO FP-S
Identity
- Trade Name
- RADIOLOGIA OMNISCOP FP-S EUDAMEDOmniscop FP-S EUDAMED
- Device Name
- OMNISCOP FP-S EUDAMED
- Model / Reference
- OMNISCOP FP-S EUDAMED95 02 000 / 95 04 000 / 95 07 000 / 95 09 000 EUDAMEDARCO FP-S EUDAMED95 02 000; 95 04 000; 95 07 000; 95 09 000; 95 05 000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055186670655 EUDAMED
- Basic UDI-DI
- B-08055186670655 EUDAMED805518667FP-SFH EUDAMED
- Direct Marketing DI
- 08055186670655 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-S 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-08055186670655 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08055186670655 | 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 32ac2d20-d7fe-4972-a896-365eb0fdf142 61 fields · synced Oct 6, 2026
- EUDAMED 881fff6d-0f1b-44b4-8eec-ac9ea22c957a-1 61 fields · synced Jun 18, 2026
- EUDAMED 881fff6d-0f1b-44b4-8eec-ac9ea22c957a-2 61 fields · synced Jun 18, 2026