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OMNISCOP DReam-S
EUDAMEDClass IIb (EU MDR)
Ref 95 05 000Model ARCO FP-SModel OMNISCOP Dream-S
Identity
- Trade Name
- OMNISCOP DReam-S EUDAMEDSTEPHANIX OMNISCOP Dream-S EUDAMED
- Device Name
- OMNISCOP Dream-S EUDAMED
- Model / Reference
- ARCO FP-S EUDAMED95 05 000 EUDAMEDOMNISCOP Dream-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055186670730 EUDAMED
- Basic UDI-DI
- 805518667FP-SFH EUDAMEDB-08055186670730 EUDAMED
- Direct Marketing DI
- 08055186670730 EUDAMED
- EMDN Code
- Z11039017 MOBILE RADIOSCOPIC UNITS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy 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 DReam-S 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 | 805518667FP-SFH | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 805518667FP-SFH | 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 60621ffc-e2d2-4985-bb55-4d94cd3d9056 61 fields · synced Oct 6, 2026
- EUDAMED 5d054f8b-b819-439d-99c4-10dbb8b13702 61 fields · synced May 18, 2026