Identity
- Trade Name
- Sedaconda ACD-L EUDAMED
- Device Name
- Sedaconda® ACD EUDAMED
- Model / Reference
- Sedaconda® ACD-S EUDAMED1026100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391530290678 EUDAMED
- Basic UDI-DI
- 539153029026001FE EUDAMED
- Unit of Use DI
- 05391530290661 EUDAMED
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Pulmonary function analysis system, adult
Sedaconda ACD-L by Sedana Medical Limited — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Manufacturer's product page: Sedaconda ACD-L
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 | 539153029026001FE | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sedana Medical Limited
- EUDAMED SRN
- IE-MF-000001734
Sources (1)
- EUDAMED 16ca88a9-8509-4ca6-89d6-5efd8d93f9f7 61 fields · synced Jul 29, 2026