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pRESET, product family

by phenox GmbH 6 variants Basic UDI-DI 426012378THROMBECTOMYF6

Shared by every variant

Manufacturer
phenox GmbH(6)
Basic UDI-DI
426012378THROMBECTOMYF6
Risk class
Class III
Legislation
MDR
EMDN category
MECHANICAL NEUROVASCULAR THROMBECTOMY AND THROMBOASPIRATION SYSTEMS
Market status
6 on the market
Official record
EUDAMED public site — Open the EUDAMED public site, choose Devices, and search for the Basic UDI-DI 426012378THROMBECTOMYF6.

Certificates

2 certificates naming this Basic UDI-DI · EUDAMED

  • 1000334607 Technical documentation · refdata.applicable-legislation.mdr supplemented
    Notified body 0297 · holder phenox GmbH · issued 4 Sep 2026 · expires 21 Mar 2029
  • 1000332692 Quality management system · refdata.applicable-legislation.mdr supplemented
    Notified body 0297 · holder phenox GmbH · issued 4 Sep 2026 · expires 20 Dec 2028

Recalls

0 recalls · FDA

No recall matched the devices on this page.

Recalls matched to the 6 devices listed on this page; other pages of the family can carry others.

Variants

6 devices · page 1 of 1

Variants of pRESET, Basic UDI-DI 426012378THROMBECTOMYF6
UDI-DISize and differences
pRESET LITE Thrombectomy Device PRE-LT-3-20 / Thrombectomy Systems04260123784171 —On the market
pRESET LITE Thrombectomy Device PRE-LT-4-20 / Thrombectomy Systems04260123784195 —On the market
pRESET STANDARD Thrombectomy Device PRE-4-20 / Thrombectomy Systems04260123784058 —On the market
pRESET STANDARD Thrombectomy Device PRE-6-30 / Thrombectomy Systems04260123784119 —On the market
pRESET STANDARD Thrombectomy Device PRES-5-40 / Thrombectomy Systems04260123784089 —On the market
pRESET STANDARD Thrombectomy Device PRES-6-50 / Thrombectomy Systems04260123784140 —On the market