GORE® ACUSEAL Vascular Graft
by W. L. Gore & Associates, Inc. 4 variants
Ref ECH060040Model GORE® ACUSEAL Vascular Graft
Expiring
CE MDR
Valid until
20 Feb 2027
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberMDR 732282 | Date31 Aug 2026 | StatusExpiring |
Certificates
- MDR 732282 Expiring
Technical documentation EU MDR
- Certifier
- BSI Group The Netherlands B.V. 2797
- Issued
- 31 Aug 2026
- Expires
- 20 Feb 2027
- Reason
- Change approved
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Expiring
Specification
- Model / Reference
- GORE® ACUSEAL Vascular Graft, ECH060040
- Primary DI / UDI-DI
- 00733132605347
- Basic UDI-DI
- 0733132200623942U
- EMDN Code
- P070102020102 Ptfe vascular prostheses, straight, reinforced
- 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 (9)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No