Identity
- Device Name
- Dental Unit EUDAMED
- Model / Reference
- SDL-C0238 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16974539960832 EUDAMED
- Basic UDI-DI
- 697453996DentalUnitM3 EUDAMED
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Dental Unit by Jiangsu Saikang Medical Equipment Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697453996DentalUnitM3 | Class I | Active |
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Manufacturer
- Manufacturer
- Jiangsu Saikang Medical Equipment Co., Ltd
- EUDAMED SRN
- CN-MF-000002228
- Authorised Representative
- Everbiz GmbH DE-AR-000008964
Sources (1)
- EUDAMED bc358f82-5924-409c-8555-bf6a9308ef2b 61 fields · synced Oct 6, 2026