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Digital Intraoral Scanner System
EUDAMEDClass I (EU MDR)
Ref S10Model S6000,S10
Identity
- Trade Name
- Digital Intraoral Scanner System EUDAMED
- Device Name
- Digital Intraoral Scannner System EUDAMED
- Model / Reference
- S6000,S10 EUDAMEDS10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974566270129 EUDAMED
- Basic UDI-DI
- 697456627S6000HJ EUDAMED
- EMDN Code
- Z12119099 VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Digital Intraoral Scanner System by Fussen 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 | 697456627S6000HJ | Class I | Active |
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Manufacturer
- Manufacturer
- Fussen Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000009373
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (1)
- EUDAMED 1237431e-2539-4f23-87bc-fb03c2ac05bb 61 fields · synced Jun 19, 2026