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Skanmobile And Variants
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 303-000018-16Ref 303-000018-14Ref 303-000018-0
Identity
- Trade Name
- SKANMOBILE DR FDA UDI
- Generic Name
- Mobile basic diagnostic x-ray system, digital FDA UDI
- Device Name
- SKANMOBILE AND VARIANTS EUDAMEDSKANMOBILE DR is a digital radiographic system designed for superior image quality featuring wireless flat panel detector and operator console for digital imaging integrated with high frequency generator. FDA UDI
- Model / Reference
- 303-000018-16 EUDAMEDFDA UDI303-000018-14 EUDAMED303-000018-0 EUDAMED
- Description
- SKANMOBILE DR is a digital radiographic system designed for superior image quality featuring wireless flat panel detector and operator console for digital imaging integrated with high frequency generator. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08904269403683 EUDAMEDFDA UDI08904269403591 EUDAMED08904269403508 EUDAMED
- Basic UDI-DI
- 890426940100377 EUDAMED
- Direct Marketing DI
- 08904269403683 EUDAMED08904269403591 EUDAMED08904269403508 EUDAMED
- 510(k) Number
- K212940 FDA UDI
- FDA Product Code
- IZL FDA UDIMQB FDA UDI
- EMDN Code
- Z11039016 MOBILE RADIOGRAPHIC UNITS EUDAMED
- GMDN Term
- Mobile basic diagnostic x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1720 FDA UDI892.1680 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
Skanmobile And Variants 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 | 890426940100377 | 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 (4)
- EUDAMED 7f63144c-ae54-468c-bc79-e509d9bb1797 61 fields · synced Jul 29, 2026
- EUDAMED 2176cb60-76bd-464f-a23b-6ed3e7d252f9 61 fields · synced May 17, 2026
- EUDAMED 88bafcd2-5192-4bdf-bc32-4b5c37386713 61 fields · synced May 17, 2026
- FDA UDI 7d18cb9e-69e3-4bf0-837a-afe80b11f0a2 34 fields · synced May 30, 2026