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Intraoral Scanner
EUDAMEDClass I (EU MDR)
Ref TF-SCAN-05Model SCAN11, SCAN-i5, SCAN-i6, SCAN33, SCAN-V5, SCAN-V6, TRIOS-11
Identity
- Trade Name
- Intraoral Scanner EUDAMED
- Device Name
- Intraoral Scanner EUDAMED
- Model / Reference
- SCAN11, SCAN-i5, SCAN-i6, SCAN33, SCAN-V5, SCAN-V6, TRIOS-11 EUDAMEDTF-SCAN-05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975006958232 EUDAMED
- Basic UDI-DI
- 697500695IOS002KF EUDAMED
- EMDN Code
- Z119003 BIOIMAGING PHOTOGRAPHY INSTRUMENTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye 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
Intraoral Scanner by Ningbo Youjoy Dental Equipment 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 | 697500695IOS002KF | Class I | Active |
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Manufacturer
- Manufacturer
- Ningbo Youjoy Dental Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000040566
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 50e86814-a549-4743-93ee-26eeb259ef6a 61 fields · synced Jun 18, 2026