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Omniscop FP
EUDAMEDClass IIb (EU MDR)
Ref 74 10 000-2; 74 12 000-2Model ARCO FPRef 74 10 000-2 / 74 12 000-2Model OMNISCOP FPRef 95 01 000 / 95 03 000 / 95 06 000 / 95 08 000Model OMNISCOP FP-SRef 95 01 000; 95 03 000; 95 06 000; 95 08 000Model ARCO FP-S
Identity
- Trade Name
- Omniscop FP EUDAMEDRADIOLOGIA OMNISCOP FP EUDAMEDRADIOLOGIA OMNISCOP FP-S EUDAMEDOmniscop FP-S EUDAMED
- Device Name
- OMNISCOP FP EUDAMEDOMNISCOP FP-S EUDAMED
- Model / Reference
- ARCO FP EUDAMED74 10 000-2; 74 12 000-2 EUDAMEDOMNISCOP FP EUDAMED74 10 000-2 / 74 12 000-2 EUDAMEDOMNISCOP FP-S EUDAMED95 01 000 / 95 03 000 / 95 06 000 / 95 08 000 EUDAMEDARCO FP-S EUDAMED95 01 000; 95 03 000; 95 06 000; 95 08 000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055186670624 EUDAMED08055186670648 EUDAMED
- Basic UDI-DI
- 805518667FPVP EUDAMEDB-08055186670624 EUDAMEDB-08055186670648 EUDAMED805518667FP-SFH EUDAMED
- Direct Marketing DI
- 08055186670624 EUDAMED08055186670648 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 (7)
- EUDAMED f3fc42f9-12bd-4718-9401-574ab275e5f6 61 fields · synced Oct 6, 2026
- EUDAMED 0a6022be-f89b-45c8-ba34-e20eda68c303 61 fields · synced May 16, 2026
- EUDAMED 40019dd9-6b99-48dd-80f8-a40f6981f494 61 fields · synced May 17, 2026
- EUDAMED f3fc42f9-12bd-4718-9401-574ab275e5f6-1 61 fields · synced Jun 9, 2026
- EUDAMED ad2e4535-72ab-4a26-bfe3-0cfa3e1adc75-1 61 fields · synced Jun 19, 2026
- EUDAMED ad2e4535-72ab-4a26-bfe3-0cfa3e1adc75-2 61 fields · synced Jun 19, 2026
- EUDAMED 11b397d6-a39c-474c-8cc5-c48b8d9d904e-1 61 fields · synced Aug 1, 2026