Identity
- Trade Name
- HKH 7900 Holder for PLS-i oxygenator EUDAMED
- Device Name
- Holder EUDAMED
- Model / Reference
- 701031554 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04037691108841 EUDAMED
- Basic UDI-DI
- 405886357664FE EUDAMED
- Direct Marketing DI
- 04037691108841 EUDAMED
- EMDN Code
- Z12050280 EXTRA-CORPOREAL CIRCULATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I 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
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
HKH 7900 Holder for PLS-i oxygenator by Maquet Cardiopulmonary GmbH — Class I — 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 | 405886357664FE | Class I | Active |
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Manufacturer
- Manufacturer
- Maquet Cardiopulmonary GmbH
- EUDAMED SRN
- DE-MF-000020091
Sources (1)
- EUDAMED a38eb966-7541-49e7-8a40-9d61314e7354 61 fields · synced Jun 18, 2026