Identity
- Trade Name
- S1-E Plus Start Up Set 2.0 EUDAMED
- Device Name
- Sendoline Start Up Set EUDAMED
- Model / Reference
- OP0009 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 17310230061574 EUDAMED
- Basic UDI-DI
- 731023999531AV EUDAMED
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Endodontic treatment EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
S1-E Plus Start Up Set 2.0 by Directa AB — Class IIa — 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 | 731023999531AV | Class IIa | Active |
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Manufacturer
- Manufacturer
- Directa AB
- EUDAMED SRN
- SE-PR-000027622
Sources (1)
- EUDAMED c559b6e6-fd5f-48ec-ade8-e257de7620e5 61 fields · synced Jun 19, 2026