Apex cannula
by Berlin Heart GmbH 3 variants
Ref C18A-020m
Active
CE MDR
Valid until
23 Jun 2031
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number4260090042830QX 04260090042809 | Date8 Jul 2026 | StatusActive |
Certificates
- G70 046068 0051 Active
Technical documentation EU MDR
- Certifier
- TÜV SÜD Product Service GmbH 0123
- Issued
- 24 Jun 2026
- Expires
- 23 Jun 2031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
- Austria
- Belgium
- Bulgaria
- Croatia
- Cyprus
- Czechia
- Denmark
- Finland
- France
- Germany
- Greece
- Hungary
- Iceland
- Ireland
- Italy
- Liechtenstein
- Luxembourg
- Netherlands
- Northern Ireland
- Norway
- Poland
- Portugal
- Romania
- Slovakia
- Slovenia
- Spain
- Sweden
Specification
- Device Name
- Apex cannula
- Model / Reference
- C18A-020m
- Primary DI / UDI-DI
- 04260090042809
- Basic UDI-DI
- 4260090042830QX
- EMDN Code
- C03010499 Extracorporeal circulation cannulas - other
- Device Class
- Class III
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000006521
Other devices from Berlin Heart GmbH
Properties
Other properties (11)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No