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Dental Digital Imaging Sensor
EUDAMEDClass IIa (EU MDR)
Ref IFU-US-01Model US980Ref 750Model DR730, DR750 US980, US990
Identity
- Trade Name
- US980 EUDAMED
- Device Name
- Dental Digital Imaging Sensor EUDAMED
- Model / Reference
- US980 EUDAMEDIFU-US-01 EUDAMEDDR730, DR750 US980, US990 EUDAMED750 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975006957501 EUDAMED
- Basic UDI-DI
- B-06975006957501 EUDAMED697500695US001KF EUDAMED
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMEDGermany 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
Category: Stationary basic diagnostic x-ray system, digital
Dental Digital Imaging Sensor by Ningbo Youjoy Dental Equipment Co., Ltd. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06975006957501 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06975006957501 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ningbo Youjoy Dental Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000040566
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED ab63f377-3daf-43c3-9b72-252584f696b8 61 fields · synced Jun 20, 2026
- EUDAMED c51cbf4b-77b8-4910-a648-5df809e0ca61 61 fields · synced May 17, 2026