Identity
- Trade Name
- Digital Intraoral Scanner System EUDAMEDFUSSEN FDA UDI
- Generic Name
- Intraoral optical scanning system FDA UDI
- Device Name
- Digital Intraoral Scanner System EUDAMED
- Model / Reference
- S6500 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974566270051 EUDAMEDFDA UDI
- Basic UDI-DI
- 697456627S6500JB EUDAMED
- Direct Marketing DI
- 06974566270051 EUDAMED
- FDA Product Code
- NOF FDA UDI
- EMDN Code
- Z12119099 VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - OTHER 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 Scanner 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 | 697456627S6500JB | 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 (2)
- EUDAMED 340a0781-1536-4490-909b-578e11f20161 61 fields · synced Jun 19, 2026
- FDA UDI a59e36e0-6ef8-4e2b-a391-19c190b63b8a 34 fields · synced May 30, 2026