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Digital Intraoral X-ray Sensor
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 602Model XVD2121 Plus, XVD2530
Identity
- Trade Name
- Digital Intraoral X-ray Sensor EUDAMED
- Device Name
- Digital Intraoral X-ray Sensor EUDAMED
- Model / Reference
- XVD2121 Plus, XVD2530 EUDAMED602 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972259246024 EUDAMED
- Basic UDI-DI
- 697225924600KS EUDAMED
- Direct Marketing DI
- 06972259246024 EUDAMED
- EMDN Code
- Z11060201 SINGLE-INPUT COMPUTED RADIOGRAPHY (CR) SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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 X-ray Sensor by Shenzhen Xpectvision Technology Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220277 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697225924600KS | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Xpectvision Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000021307
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (2)
- EUDAMED 255a6002-03d3-44b4-b2c9-2ec1d77c0c01 61 fields · synced Jun 19, 2026
- FDA 510(k) K220277 1 fields · synced May 18, 2026