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SCAN-i6
EUDAMEDClass I (EU MDR)
Ref 829Model 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
- SCAN-i6 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 EUDAMED829 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974721258290 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
SCAN-i6 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 01eabb9d-e745-4edc-8620-9498f1b7fc5d 61 fields · synced Oct 6, 2026