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DefiMax biphasic
EUDAMEDClass IIb (EU MDR)
Ref DEFIMAXBIPHASICModel DefiMax biphasic
Identity
- Trade Name
- DefiMax biphasic EUDAMED
- Device Name
- DefiMax biphasic - clinical defibrillator EUDAMED
- Model / Reference
- DefiMax biphasic EUDAMEDDEFIMAXBIPHASIC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 59044737177600 EUDAMED
- Basic UDI-DI
- B-59044737177600 EUDAMED
- EMDN Code
- Z12030502 MANUAL 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 biphasic 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-59044737177600 | Class IIb | Active |
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Manufacturer
- Manufacturer
- EMTEL Śliwa spółka komandytowa
- EUDAMED SRN
- PL-MF-000006848
Sources (1)
- EUDAMED 0330fb35-c967-4c82-9051-096e7b24afe6 61 fields · synced Oct 6, 2026