Identity
- Device Name
- Digital Intraoral lmaging Plate System EUDAMED
- Model / Reference
- F220 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974566272079 EUDAMED
- Basic UDI-DI
- 697456627F220J9 EUDAMED
- EMDN Code
- Z11060201 SINGLE-INPUT COMPUTED RADIOGRAPHY (CR) SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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 lmaging Plate System by Fussen Technology Co., Ltd. — Class IIa — 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 | 697456627F220J9 | 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 (1)
- EUDAMED 4938f1b5-b43a-4ddd-b916-21bbb547eba9 61 fields · synced Jun 18, 2026