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NeVa

by Vesalio, LLC EUDAMED

Active European Union

Ref VN-3017-32RRModel NeVa VS

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0851279008NEVA2J Basic UDI-DIDate9 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 02 Supplemented

    Technical documentation EU MDR

    Notified body
    Notified body 0297
    Issued
    22 Jan 2026
    Expires
    14 Sep 2027
    Reason
    Change approved
  • 1000271658 Supplemented

    Quality management system EU MDR

    Notified body
    Notified body 0297
    Issued
    22 Jan 2026
    Expires
    7 Sep 2027
    Reason
    Change approved

Specification

EUDAMED

Device Name
NeVa System
Model / Reference
NeVa VS, VN-3017-32RR
Primary DI / UDI-DI
00851279008880
Basic UDI-DI
0851279008NEVA2J
EMDN Code
C010401020501 Manual cardiac thrombectomy and thromboaspiration systems
Device Class
Class III
Market of Registration
Greece

Manufacturer details

EUDAMED SRN
US-MF-000016994
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Vesalio, Inc.

See all devices from Vesalio, Inc. →

Properties

  • Sterile

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