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Scan33
EUDAMEDClass I (EU MDR)
Ref 830Model IOS-11, 3DS Mega, 3DS Ultra, SCAN11, SCAN-i5, SCAN-i6, SCAN33, SCAN-V5, SCAN-V6, ORAL-O3, SCAN-O5, SCAN-O6
Identity
- Trade Name
- SCAN33 EUDAMED
- Device Name
- Intraoral Scanner EUDAMED
- Model / Reference
- IOS-11, 3DS Mega, 3DS Ultra, SCAN11, SCAN-i5, SCAN-i6, SCAN33, SCAN-V5, SCAN-V6, ORAL-O3, SCAN-O5, SCAN-O6 EUDAMED830 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974721258306 EUDAMED
- Basic UDI-DI
- 697472125IOS001K3 EUDAMED
- EMDN Code
- Z119003 BIOIMAGING PHOTOGRAPHY INSTRUMENTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Scan33 by Ningbo Runyes Medical Instrument Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697472125IOS001K3 | Class I | Active |
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Manufacturer
- Manufacturer
- Ningbo Runyes Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000014741
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 4e00e8c9-2f68-43cb-8015-e5e7819ee229 61 fields · synced Jun 20, 2026