Identity
- Trade Name
- Sedaconda® ACD Starter Kit EUDAMED
- Device Name
- Sedaconda ACD Starter Kit EUDAMED
- Model / Reference
- 2026050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391530290883 EUDAMED
- Basic UDI-DI
- 539153029026005FN EUDAMED
- EMDN Code
- A020199,R9099 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- The Sedaconda ACD starter kit contains one Sedaconda ACD-S, and all the ancillary accessories required to set up and start using the device. A simplified picture of the Sedaconda ACD set-up is printed inside the box, to guide the user. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Sedaconda® ACD Starter Kit by Sedana Medical Limited — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: Instruction for Use (IFU)
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 | 539153029026005FN | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sedana Medical Limited
- EUDAMED SRN
- IE-PR-000001737
Sources (1)
- EUDAMED 7461762b-5d78-42b4-b45c-dc84b12b9448 61 fields · synced Jun 18, 2026