GORE® CARDIOFORM Septal Occluder
by W. L. Gore & Associates, Inc. 3 variants
Ref GSXE0025Model GORE® CARDIOFORM Septal Occluder
Active
CE MDR
Valid until
16 Aug 2031
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberMDR 731002 | Date20 Jul 2026 | StatusActive |
Certificates
- MDR 731002 Active
Technical documentation EU MDR
- Certifier
- BSI Group The Netherlands B.V. 2797
- Issued
- 20 Jul 2026
- Expires
- 16 Aug 2031
- Valid from
- 17 Aug 2026
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- GORE® CARDIOFORM Septal Occluder, GSXE0025
- Primary DI / UDI-DI
- 00733132617647
- Basic UDI-DI
- 0733132200623432B
- EMDN Code
- P07040302 Cardiac occluders, atrial septal defects
- Device Class
- Class III
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000001141
- Authorised representative
- W.L. Gore & Associates B.V. NL-AR-000000168
Other devices from W. L. Gore & Associates, Inc.
Properties
Other properties (10)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No