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Envi™-SR

by NeuroVasc Technologies, Inc. United States EUDAMED

Ref FG-004-037 Model Envi-SR 5x40

EMDN C010402020702

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-00852252007302 Basic UDI-DIDate6 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Envi-SR
Model / Reference
Envi-SR 5x40, FG-004-037
Primary DI / UDI-DI
00852252007302
Basic UDI-DI
B-00852252007302
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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 715f4bac-d083-4fd1-b804-c5d7c0c600eb 61 fields · synced 22 Oct 2026