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STEPHANIX OMNISCOP Dream-S
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 95 02 000 / 95 04 000 / 95 07 000 / 95 09 000Model OMNISCOP Dream-SRef 95 02 000; 95 04 000; 95 07 000; 95 09 000Model ARCO FP-S
Identity
- Trade Name
- STEPHANIX OMNISCOP Dream-S EUDAMEDOMNISCOP DReam-S EUDAMEDSTEPHANIX FDA UDI
- Generic Name
- Mobile general-purpose fluoroscopic x-ray system, digital FDA UDI
- Device Name
- OMNISCOP Dream-S EUDAMEDThis is a mobile X-ray device with a Flat Panel detector used for radiological guidance and visualization during diagnostic, interventional and surgical procedures. In particular, the device is to be applied during orthopedic, neuro, abdominal, vascular, thoracic and cardiac procedures. It can be used on all patients except pediatric patients within the limit of the device. FDA UDI
- Model / Reference
- OMNISCOP Dream-S EUDAMEDFDA UDI95 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 EUDAMED
- Description
- This is a mobile X-ray device with a Flat Panel detector used for radiological guidance and visualization during diagnostic, interventional and surgical procedures. In particular, the device is to be applied during orthopedic, neuro, abdominal, vascular, thoracic and cardiac procedures. It can be used on all patients except pediatric patients within the limit of the device. FDA UDI
Identifiers
- Catalog Number
- 95 02 000 FDA UDI
- Primary DI / UDI-DI
- 08055186670303 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08055186670303 EUDAMED805518667FP-SFH EUDAMED
- Direct Marketing DI
- 08055186670303 EUDAMED
- 510(k) Number
- K211777 FDA UDI
- FDA Product Code
- OWB FDA UDIOXO FDA UDI
- EMDN Code
- Z11039017 MOBILE RADIOSCOPIC UNITS EUDAMED
- GMDN Term
- Mobile general-purpose fluoroscopic x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1650 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
STEPHANIX OMNISCOP Dream-S by A.T.S. Applicazione Tecnologie Speciali s.r.l. — Class IIb — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08055186670303 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08055186670303 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- A.T.S. Applicazione Tecnologie Speciali s.r.l.
- EUDAMED SRN
- IT-MF-000010734
Sources (4)
- EUDAMED c677f41f-a14e-47fd-a728-c5a1c24c4010 61 fields · synced Oct 6, 2026
- EUDAMED a77be2a7-6d7b-469a-aee5-425cbd296ba7 61 fields · synced May 18, 2026
- FDA UDI f598004f-7c64-4127-9ae5-c9fdd039f05b 35 fields · synced May 30, 2026
- EUDAMED a77be2a7-6d7b-469a-aee5-425cbd296ba7-1 61 fields · synced Jun 10, 2026