pRESET STANDARD Thrombectomy Device
by phenox GmbH Germany EUDAMED
Ref PRES-5-40Model Thrombectomy Systems
EMDN C010402020702
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number1000332692 | Date4 Sep 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- 1000334607 Supplemented
Technical documentation EU MDR
- Notified body
- Notified body 0297
- Issued
- 4 Sep 2026
- Expires
- 21 Mar 2029
- Reason
- Change approved
- 1000332692 Supplemented
Quality management system EU MDR
- Notified body
- Notified body 0297
- Issued
- 4 Sep 2026
- Expires
- 20 Dec 2028
- Reason
- Change approved
Specification
- Model / Reference
- Thrombectomy Systems, PRES-5-40
- Primary DI / UDI-DI
- 04260123784089
- Basic UDI-DI
- 426012378ThrombectomyF6
- EMDN Code
- C010402020702 Mechanical peripheral thrombectomy and thromboaspiration systems
- Device Class
- Class III
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000006524
Other devices from phenox GmbH
Properties & raw data
Show properties, registry sources and raw records
Other properties (11)
- Implantable: No
- 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
Sources (1)
- EUDAMED 6209a4e6-d8be-481b-9f24-170d60e760f4