Identity
- Device Name
- Intraoral Scanner EUDAMED
- Model / Reference
- SCAN-i5 EUDAMEDIOS-11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16975586210031 EUDAMED
- Basic UDI-DI
- 697558621IntraoralGC EUDAMED
- EMDN Code
- Z11069005 DIAGNOSTIC IMAGING WORKSTATIONS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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: Tissue specimen x-ray system IVD
Intraoral Scanner by Shenzhen Sunmc Dental Technology Co., Ltd. — Class I — CE/MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Tissue specimen x-ray system IVD.
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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 | 697558621IntraoralGC | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen Sunmc Dental Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000049797
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED 07e29ed1-63ca-4456-a1e1-d4d8eb861ee7 61 fields · synced Oct 7, 2026