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Semi-automatic external defibrillator
EUDAMEDClass IIb (EU MDR)
Ref 204Model i3Ref 205Model i5
Identity
- Trade Name
- Semi-automatic external defibrillator EUDAMED
- Device Name
- Semi-automatic external defibrillator EUDAMED
- Model / Reference
- i3 EUDAMED204 EUDAMEDi5 EUDAMED205 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970658140646 EUDAMED06970658140639 EUDAMED
- Basic UDI-DI
- B-06970658140646 EUDAMEDB-06970658140639 EUDAMED
- EMDN Code
- Z12030503 AUTOMATIC DEFIBRILLATORS EUDAMEDZ12030501 SEMI-AUTOMATIC DEFIBRILLATORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMEDItaly 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
Semi-automatic external defibrillator by Ambulanc(Shenzhen)Tech.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-06970658140646 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Ambulanc(Shenzhen)Tech.Co., Ltd.
- EUDAMED SRN
- CN-MF-000010435
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 1f7d8df2-3b32-4792-90d5-6cf26717bb0f 61 fields · synced Oct 6, 2026
- EUDAMED 84dc0988-6e46-4c97-afe1-548324c75df6 61 fields · synced May 17, 2026