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Intraoral Scanner
EUDAMEDClass I (EU MDR)
Ref VDS100PROModel VLS100, VLS200, VLS300,VDS100, VDS100PRO, VDS100PRO+, VDS200,VDS300, VDS400Ref VDS400Ref VDS300Ref VDS200Ref VDS100Ref VLS200
Identity
- Trade Name
- Intraoral Scanner EUDAMED
- Device Name
- Intraoral Scanner EUDAMED
- Model / Reference
- VLS100, VLS200, VLS300,VDS100, VDS100PRO, VDS100PRO+, VDS200,VDS300, VDS400 EUDAMEDVDS100PRO EUDAMEDVDS400 EUDAMEDVDS300 EUDAMEDVDS200 EUDAMEDVDS100 EUDAMEDVLS200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974668765059 EUDAMED06974668765097 EUDAMED06974668765080 EUDAMED06974668765073 EUDAMED06974668765042 EUDAMED06974668765028 EUDAMED
- Basic UDI-DI
- 697466876002R3 EUDAMED
- Direct Marketing DI
- 06974668765059 EUDAMED06974668765097 EUDAMED06974668765080 EUDAMED06974668765073 EUDAMED06974668765042 EUDAMED06974668765028 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 (6)
- EUDAMED 0d5142f8-a300-4a41-a695-4cdefc077f75 61 fields · synced Jul 24, 2026
- EUDAMED 43ef8280-e80e-4e14-b687-172eaf7696de 61 fields · synced May 18, 2026
- EUDAMED 7d56ab6d-da53-40c6-9d82-b6ab299a0f4b 61 fields · synced May 18, 2026
- EUDAMED 6e00a7e3-d694-464c-b3ec-40ce8b8f5b6a 61 fields · synced May 18, 2026
- EUDAMED bd06b321-53d0-44eb-a1ec-20bfdd93b598 61 fields · synced May 18, 2026
- EUDAMED f0afbbfd-2b9d-4bd1-8aff-f31984d53409 61 fields · synced May 19, 2026