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Us990
EUDAMEDClass IIa (EU MDR)
Ref 751Model DR730, DR750 US980, US990Ref IFU-US-01Model US990Ref 752
Identity
- Trade Name
- US990 EUDAMEDDR730 EUDAMED
- Device Name
- Dental Digital Imaging Sensor EUDAMED
- Model / Reference
- DR730, DR750 US980, US990 EUDAMED751 EUDAMEDUS990 EUDAMEDIFU-US-01 EUDAMED752 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975006957518 EUDAMED06975006957525 EUDAMED
- Basic UDI-DI
- 697500695US001KF EUDAMEDB-06975006957518 EUDAMED
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMEDNetherlands EUDAMEDCroatia 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
Us990 by Ningbo Youjoy Dental Equipment Co., Ltd. — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 697500695US001KF | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697500695US001KF | 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 (3)
- EUDAMED 68f8e768-c028-4361-af4f-3b32caf70cb7 61 fields · synced Jul 12, 2026
- EUDAMED 579b7c36-a570-4843-ad6c-e6da80f07d8a 61 fields · synced May 17, 2026
- EUDAMED a915a72e-15d9-4f3f-a554-30a5d1dd6a03 61 fields · synced Jul 9, 2026