GORE® DrySeal Flex Introducer Sheath
by W. L. Gore & Associates, Inc. United States EUDAMED
Ref DSF1945Model GORE® DrySeal Flex Introducer Sheath EMDN C0502
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0733132302562403W | Date17 Jul 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- MDR 764343 Supplemented
Technical documentation EU MDR
- Notified body
- Notified body 2797
- Issued
- 20 Aug 2026
- Expires
- 26 Apr 2028
- Reason
- Add device or group
Specification
- Model / Reference
- GORE® DrySeal Flex Introducer Sheath, DSF1945
- Primary DI / UDI-DI
- 00733132628186
- Basic UDI-DI
- 0733132302562403W
- EMDN Code
- C0502 Cardiovascular introducer sheaths, valved
- Device Class
- Class III
- 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 & raw data
Show properties, registry sources and raw records
Other properties (12)
- Implantable: No
- 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
Sources (1)
- EUDAMED 00733132628186|0733132302562403W