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Digital Intraoral Scannner System
EUDAMEDFDA UDIClass I (EU MDR)
Ref Rule13, Annex VIII Model S7000 S7000 Premium
Identity
- Trade Name
- Digital Intraoral Scannner System EUDAMEDFUSSEN FDA UDI
- Generic Name
- Intraoral optical scanning system FDA UDI
- Device Name
- Digital Intraoral Scannner System EUDAMED
- Model / Reference
- S7000 S7000 Premium EUDAMEDRule13, Annex VIII EUDAMEDS7000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974566270020 EUDAMEDFDA UDI
- Basic UDI-DI
- 697456627S7000HR EUDAMED
- Direct Marketing DI
- 06974566270020 EUDAMED
- FDA Product Code
- NOF FDA UDI
- EMDN Code
- Z11030402 SYSTEMS FOR INTRAORAL DIGITAL VIDEORADIOGRAPHY EUDAMED
- GMDN Term
- Intraoral optical scanning system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3661 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Digital Intraoral Scannner System by Fussen Technology Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697456627S7000HR | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Fussen Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000009373
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (3)
- EUDAMED ed0b6d6d-5455-4872-9d2a-09fc38cc5669 61 fields · synced Jul 23, 2026
- FDA UDI 49f82bc2-386d-4b3c-9bdd-30d2f4357266 34 fields · synced May 29, 2026
- EUDAMED ed0b6d6d-5455-4872-9d2a-09fc38cc5669-1 61 fields · synced Jun 10, 2026