Identity
- Trade Name
- PLS Set Plus EUDAMED
- Device Name
- PLS Set Plus EUDAMED
- Model / Reference
- BE-PLS 2051 EUDAMED701068389 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04058863006666 EUDAMED
- Basic UDI-DI
- B-04058863006666 EUDAMED
- EMDN Code
- C03010301 CARDIOPULMONARY SUPPORT KITS (C.P.S. AND ECMO) EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
PLS Set Plus by Maquet Cardiopulmonary GmbH — Class III — 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-04058863006666 | Class III | Active |
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Manufacturer
- Manufacturer
- Maquet Cardiopulmonary GmbH
- EUDAMED SRN
- DE-MF-000020091
Sources (1)
- EUDAMED 618f8e9d-59f5-4d84-9042-8393019662d2 61 fields · synced Sep 18, 2026