Identity
- Trade Name
- DefiMax AED EUDAMED
- Device Name
- DefiMax AED - semi-automatic defibrillator EUDAMED
- Model / Reference
- DefiMax AED EUDAMEDDEFIMAXAED EUDAMED
Identifiers
- Primary DI / UDI-DI
- 59044737177914 EUDAMED
- Basic UDI-DI
- B-59044737177914 EUDAMED
- EMDN Code
- Z12030501 SEMI-AUTOMATIC DEFIBRILLATORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
DefiMax AED by EMTEL Śliwa spółka komandytowa — 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-59044737177914 | Class IIb | Active |
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Manufacturer
- Manufacturer
- EMTEL Śliwa spółka komandytowa
- EUDAMED SRN
- PL-MF-000006848
Sources (1)
- EUDAMED 5ebff427-f24b-49da-9200-dabb6ca502e6 61 fields · synced Oct 7, 2026