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Radiologia Omniscop Fp-S
EUDAMEDClass IIb (EU MDR)
Ref 95 05 000Model OMNISCOP FP-SModel 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 05 000 EUDAMEDARCO FP-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055186670631 EUDAMED
- Basic UDI-DI
- B-08055186670631 EUDAMED805518667FP-SFH EUDAMED
- Direct Marketing DI
- 08055186670631 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-08055186670631 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08055186670631 | 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 6f51f84f-3a6c-4403-8b4b-d66474708d38 61 fields · synced Oct 6, 2026
- EUDAMED 81638221-34e9-4e89-b03b-2bfa48cbd9c5 61 fields · synced Jun 19, 2026