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Intraoral Digital Impression Instrument
EUDAMEDClass I (EU MDR)
Ref 605Model QScan7000
Identity
- Trade Name
- Intraoral Digital Impression Instrument EUDAMED
- Device Name
- Intraoral Digital Impression Instrument EUDAMED
- Model / Reference
- QScan7000 EUDAMED605 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972259246055 EUDAMED
- Basic UDI-DI
- 697225924605L4 EUDAMED
- Direct Marketing DI
- 06972259246055 EUDAMED
- EMDN Code
- Z11030402 SYSTEMS FOR INTRAORAL DIGITAL VIDEORADIOGRAPHY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Hungary 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 Digital Impression Instrument by Shenzhen Xpectvision Technology 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 | 697225924605L4 | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen Xpectvision Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000021307
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED 7fb4d693-3628-415b-8391-cabb99a126a5 61 fields · synced Jun 19, 2026