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Digital Intraoral Imaging Plate System
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref F210
Identity
- Trade Name
- Digital Intraoral Imaging Plate System EUDAMED
- Device Name
- Digital Intraoral Imaging Plate System EUDAMED
- Model / Reference
- F210 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974566272109 EUDAMED
- Basic UDI-DI
- B-06974566272109 EUDAMED
- EMDN Code
- Z1103040102 EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland 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
Category: Dental digital imaging sensor, intraoral
Digital Intraoral Imaging Plate System by Fussen Technology Co., Ltd. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192766 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06974566272109 | 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 bf1ca5ee-1ad3-4b9d-aca5-e72e6a8d5b1a 61 fields · synced Jul 23, 2026
- FDA 510(k) K192766 1 fields · synced May 18, 2026