Identity
- Trade Name
- Heater Unit HU 35, 110-115V EUDAMED
- Device Name
- Heater Unit HU 35, 110-115V EUDAMED
- Model / Reference
- 701072163 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04058863041308 EUDAMED
- Basic UDI-DI
- B-04058863041308 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, 110-115V 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-04058863041308 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Maquet Cardiopulmonary GmbH
- EUDAMED SRN
- DE-MF-000020091
Sources (1)
- EUDAMED f3c3aacb-df9d-4652-a920-53f4064beaf3 61 fields · synced Oct 7, 2026