Identity
- Trade Name
- Cardiohelp II EGB / NIST EUDAMED
- Device Name
- Cardiohelp II EGB EUDAMED
- Model / Reference
- 701082032 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04058863335445 EUDAMED
- Basic UDI-DI
- 405886333545DK EUDAMED
- Direct Marketing DI
- 04058863335445 EUDAMED
- EMDN Code
- Z12050280 EXTRA-CORPOREAL CIRCULATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMEDEUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Cardiohelp II EGB / NIST by Maquet Cardiopulmonary GmbH — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 405886333545DK | Class IIb | Active |
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Manufacturer
- Manufacturer
- Maquet Cardiopulmonary GmbH
- EUDAMED SRN
- DE-MF-000020091
Sources (2)
- EUDAMED 4b674929-1f4f-4e1b-ab66-95a08bd1dd16 61 fields · synced Jun 19, 2026
- EUDAMED cd902c10-fd15-481c-b61a-6135b706c385 61 fields · synced Jun 19, 2026