Identity
- Trade Name
- XPLUS EUDAMED
- Device Name
- Integral Dental Units EUDAMED
- Model / Reference
- XPLUS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970932628952 EUDAMED
- Basic UDI-DI
- B-06970932628952 EUDAMED
- EMDN Code
- Q0101010201 DENTAL BASE CEMENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye 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 composite resin
Xplus by Foshan Sunlight medical equipment Co.Ltd. — Class IIa — 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/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06970932628952 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Foshan Sunlight medical equipment Co.Ltd.
- EUDAMED SRN
- CN-MF-000014572
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (1)
- EUDAMED 07f4c057-3241-4b89-ab25-1b678824dba3 61 fields · synced Jun 18, 2026