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Envi™-SR

by NeuroVasc Technologies, Inc. EUDAMED

Active European Union

Ref FG-004-016Model Envi-SR 4x35

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-00852252007272 Basic UDI-DIDate6 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Envi-SR
Model / Reference
Envi-SR 4x35, FG-004-016
Primary DI / UDI-DI
00852252007272
Basic UDI-DI
B-00852252007272
EMDN Code
C010402020702 Mechanical peripheral thrombectomy and thromboaspiration systems
Device Class
Class III
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000017356
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from NeuroVasc Technologies, Inc.

See all devices from NeuroVasc Technologies, Inc. →

Properties

  • Sterile

Other properties (10)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No