Identity
- Device Name
- INTRASKAN DC AND IT'S VARIANTS EUDAMED
- Model / Reference
- 303-000011-12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08904269400002 EUDAMED
- Basic UDI-DI
- 890426940100173 EUDAMED
- Direct Marketing DI
- 08904269400002 EUDAMED
- EMDN Code
- Z1103040102 EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Belgium 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
Category: Dental digital imaging sensor, intraoral
Intraskan Dc And It's Variants by Skanray Technologies Limited — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 890426940100173 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Skanray Technologies Limited
- EUDAMED SRN
- IN-MF-000034819
- Authorised Representative
- SKANRAY EUROPE SRL IT-AR-000013034
Sources (1)
- EUDAMED d25a15aa-ebdc-45b9-81ac-02803d3df018 61 fields · synced Jun 17, 2026