GORE® DrySeal Flex Introducer Sheath
by W. L. Gore & Associates, Inc. 29 variants
Ref DSF2145Model GORE® DrySeal Flex Introducer Sheath
Active
CE MDR
Valid until
26 Apr 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberMDR 764343 | Date20 Aug 2026 | StatusActive |
Certificates
- MDR 764343 Active
Technical documentation EU MDR
- Certifier
- BSI Group The Netherlands B.V. 2797
- Issued
- 20 Aug 2026
- Expires
- 26 Apr 2028
- Reason
- Add device or group
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
- Austria
- Denmark
- Finland
- Germany
- Iceland
- Ireland
- Liechtenstein
- Luxembourg
- Netherlands
- Norway
- Sweden
Specification
- Model / Reference
- GORE® DrySeal Flex Introducer Sheath, DSF2145
- Primary DI / UDI-DI
- 00733132628209
- Basic UDI-DI
- 0733132302562403W
- EMDN Code
- C0502 Cardiovascular introducer sheaths, valved
- 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 (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