Identity
- Trade Name
- SL8500 EUDAMED
- Device Name
- Integral Dental Units EUDAMED
- Model / Reference
- SL8500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970932628549 EUDAMED
- Basic UDI-DI
- B-06970932628549 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
Sl8500 by Foshan Sunlight medical equipment Co.Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-06970932628549 | 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 02c7f7eb-39f2-403d-bac0-cc516218d346 61 fields · synced Jul 14, 2026