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Intraoral Scanner
EUDAMEDClass I (EU MDR)
Ref VLS100Model VLS100, VLS200, VLS300,VDS100, VDS100PRO, VDS100PRO+, VDS200,VDS300, VDS400
Identity
- Trade Name
- Intraoral Scanner EUDAMED
- Device Name
- Intraoral Scanner EUDAMED
- Model / Reference
- VLS100, VLS200, VLS300,VDS100, VDS100PRO, VDS100PRO+, VDS200,VDS300, VDS400 EUDAMEDVLS100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974668765011 EUDAMED
- Basic UDI-DI
- 697466876002R3 EUDAMED
- Direct Marketing DI
- 06974668765011 EUDAMED
- EMDN Code
- Z11030402 SYSTEMS FOR INTRAORAL DIGITAL VIDEORADIOGRAPHY 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
Intraoral Scanner by Hunan Vsmile Biotechnology 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 | 697466876002R3 | Class I | Active |
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Manufacturer
- Manufacturer
- Hunan Vsmile Biotechnology Co., Ltd
- EUDAMED SRN
- CN-MF-000051840
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (1)
- EUDAMED e6095d5b-3447-437d-8d2d-44e502cbde12 61 fields · synced Jun 18, 2026