PLS Set Plus
by Maquet Cardiopulmonary GmbH 2 variants
Ref 701077201Model BE-PLS 2050 / BE-PLS 2051
Active
CE MDR
Valid until
18 Dec 2030
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number405886330769DN 04058863307695 | Date20 Feb 2026 | StatusActive |
Certificates
- G70 067154 0007 Active
Technical documentation EU MDR
- Certifier
- TÜV SÜD Product Service GmbH 0123
- Issued
- 19 Dec 2025
- Expires
- 18 Dec 2030
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- PLS Set / PLS Set Plus
- Model / Reference
- BE-PLS 2050 / BE-PLS 2051, 701077201
- Primary DI / UDI-DI
- 04058863307695
- Basic UDI-DI
- 405886330769DN
- EMDN Code
- C03010301 Cardiopulmonary support kits (c.p.s. and ecmo)
- Device Class
- Class III
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000020091
Other devices from Maquet Cardiopulmonary GmbH
Properties
Other properties (10)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No