Identity
- Trade Name
- Sedaconda ACD Starter Kit EUDAMED
- Device Name
- Starter kit EUDAMED
- Model / Reference
- 2026040 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391530290784 EUDAMED
- Basic UDI-DI
- 53915302902026040EUCE EUDAMED
- EMDN Code
- A020199,R9099 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Sedaconda ACD (Anaestethic Conserving Device) is intended for administering isoflurane or sevoflurane to invasively sedated patients. The Starter kit Procedure Pack contains the Sedaconda ACD with the required accessories to set up a patient. 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 | 53915302902026040EUCE | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sedana Medical Limited
- EUDAMED SRN
- IE-PR-000001737
Sources (1)
- EUDAMED c0c7ca9f-2eef-48a0-9346-ae6078485226 61 fields · synced Jun 18, 2026