PerQseal® Elite Closure Device
by Vivasure Medical Ltd. Ireland EUDAMED
Ref DP4-FA1-4-GModel DP4-FA1-4 EMDN C900199
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberG70 072208 0004 | Date20 Jun 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- G70 072208 0004 Supplemented
Technical documentation EU MDR
- Notified body
- TÜV SÜD Product Service GmbH 0123
- Issued
- 20 Jun 2025
- Expires
- 10 Apr 2030
- Reason
- Change approved
Specification
- Device Name
- PerQseal® Elite Closure Device
- Model / Reference
- DP4-FA1-4, DP4-FA1-4-G
- Primary DI / UDI-DI
- 05391533180419
- Basic UDI-DI
- 539153318DP4FA1VCDV7
- EMDN Code
- C900199 Haemostasis systems - other
- Device Class
- Class III
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- IE-MF-000000651
Other devices from Vivasure Medical Ltd.
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 422708ed-14b2-487a-8d74-6be0f2b678eb