Identity
- Trade Name
- Acoresmed EUDAMED
- Device Name
- Automated external defibrillator EUDAMED
- Model / Reference
- A112 EUDAMEDA102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974442401036 EUDAMED06974442401012 EUDAMED
- Basic UDI-DI
- B-06974442401036 EUDAMEDB-06974442401012 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
Acoresmed by Acoresmed 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-06974442401036 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Acoresmed Co., Ltd.
- EUDAMED SRN
- CN-MF-000020037
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 7e20a58d-ef86-48e1-b9e1-d33cb3675988 61 fields · synced Oct 6, 2026
- EUDAMED f8b43e4c-954f-4af0-ba7e-92a93aa23e7e 61 fields · synced May 19, 2026