Identity
- Trade Name
- iAED-S1 EUDAMED
- Device Name
- Automated External Defibrillator EUDAMED
- Model / Reference
- iAED-S1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973315550192 EUDAMED
- Basic UDI-DI
- B-06973315550192 EUDAMED
- EMDN Code
- Z12030501 SEMI-AUTOMATIC DEFIBRILLATORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
iAED-S1 by Jousing medical co., ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06973315550192 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Jousing medical co., ltd.
- EUDAMED SRN
- CN-MF-000008915
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED 84d1947e-d205-406e-ae3f-1c38e5601d7e 61 fields · synced Jul 12, 2026