HLS Set Advanced 7.0 - Bioline Coating
by Maquet Cardiopulmonary GmbH
Ref 701077144Model BE-HLS 7050 / BE-HLS 5050
Active
CE MDR
Valid until
15 Feb 2029
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number405886330765DE 04058863307657 | Date26 May 2026 | StatusActive |
Certificates
- G70 067154 0008 Active
Technical documentation EU MDR
- Certifier
- TÜV SÜD Product Service GmbH 0123
- Issued
- 16 Feb 2024
- Expires
- 15 Feb 2029
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
- Austria
- Belgium
- Bulgaria
- Croatia
- Cyprus
- Czechia
- Denmark
- Estonia
- Finland
- France
- Germany
- Greece
- Hungary
- Iceland
- Ireland
- Italy
- Latvia
- Liechtenstein
- Lithuania
- Luxembourg
- Malta
- Netherlands
- Northern Ireland
- Norway
- Poland
- Portugal
- Romania
- Slovakia
- Slovenia
- Spain
- Sweden
- Türkiye
Specification
- Device Name
- HLS Set Advanced 7.0/ 5.0
- Model / Reference
- BE-HLS 7050 / BE-HLS 5050, 701077144
- Primary DI / UDI-DI
- 04058863307657
- Basic UDI-DI
- 405886330765DE
- 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