Identity
- Trade Name
- Heater Unit HU 35 EUDAMED
- Device Name
- Heater Unit HU 35, 110-115 V, Base Unit EUDAMED
- Model / Reference
- 701072131 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04058863040929 EUDAMED
- Basic UDI-DI
- B-04058863040929 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
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
Heater Unit HU 35 by Maquet Cardiopulmonary GmbH — 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-04058863040929 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Maquet Cardiopulmonary GmbH
- EUDAMED SRN
- DE-MF-000020091
Sources (1)
- EUDAMED 7f81f826-7e48-4106-86be-23f1f5f41fce 61 fields · synced Jun 18, 2026