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303-000187-2
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 303-000187-2Model SKAN C AND VARIANTS
Identity
- Trade Name
- Skan C Mobile C - Arm X - Ray system FDA UDI
- Generic Name
- Portable general-purpose fluoroscopic x-ray system, digital FDA UDI
- Device Name
- SKAN-C, is a mobile X-Ray C-Arm fluoroscopic device to assist in guiding medical intervention surgical procedures. The device can also be used for radiographic applications. FDA UDI
- Model / Reference
- SKAN C AND VARIANTS EUDAMED303-000187-2 EUDAMEDF303-000187-2 FDA UDI
- Description
- SKAN-C, is a mobile X-Ray C-Arm fluoroscopic device to assist in guiding medical intervention surgical procedures. The device can also be used for radiographic applications. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08904269405519 EUDAMEDFDA UDI
- Basic UDI-DI
- 890426940100275 EUDAMED
- Direct Marketing DI
- 08904269405519 EUDAMED
- 510(k) Number
- K170946 FDA UDI
- FDA Product Code
- OWB FDA UDIOXO FDA UDI
- EMDN Code
- Z11039017 MOBILE RADIOSCOPIC UNITS EUDAMED
- GMDN Term
- Portable 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
- Belgium 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
303-000187-2 by Skanray Technologies Limited — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 890426940100275 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Skanray Technologies Limited
- EUDAMED SRN
- IN-MF-000034819
- Authorised Representative
- SKANRAY EUROPE SRL IT-AR-000013034
Sources (2)
- EUDAMED fe78c15a-d834-49c9-9112-9aeaf8994fd2 61 fields · synced Jun 20, 2026
- FDA UDI 76c05ccc-1d90-4e98-b4fb-b9b0b30b2542 34 fields · synced May 30, 2026