Identity
- Trade Name
- FUSSEN EUDAMED
- Device Name
- Digital Intraoral X-ray Imaging System EUDAMED
- Model / Reference
- F100 size#1 EUDAMEDF100 size#2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974566272031 EUDAMED06974566272048 EUDAMED
- Basic UDI-DI
- B-06974566272031 EUDAMEDB-06974566272048 EUDAMED
- EMDN Code
- Z11030402 SYSTEMS FOR INTRAORAL DIGITAL VIDEORADIOGRAPHY EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMEDBulgaria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Fussen by Fussen Technology Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06974566272031 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Fussen Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000009373
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED dae90167-a415-4691-969f-8634af2a3c6a 61 fields · synced Jul 28, 2026
- EUDAMED 07413768-8a2e-432c-91c9-442242dc860f 61 fields · synced May 18, 2026