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Barostim NEO™ Generator

by CVRx, Inc. United States EUDAMED

Ref 100054-201Model 2102

EMDN J0209

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number00859144004524J5 Basic UDI-DIDate8 Jul 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 745.059 Issued

    Quality management system EU MDR

    Notified body
    Notified body 0050
    Issued
    30 Jun 2026
    Expires
    8 Apr 2030
  • TD745.059 Issued

    Technical documentation EU MDR

    Notified body
    Notified body 0050
    Issued
    30 Jun 2026
    Expires
    8 Apr 2030

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
2102, 100054-201
Primary DI / UDI-DI
00859144004005
Basic UDI-DI
00859144004524J5
EMDN Code
J0209 Carotid sinus implantable neurostimulators and leads
Device Class
Class III
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000001082
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Cvrx, Inc.

See all devices from Cvrx, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
Other properties (11)
  • 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

Sources (1)

  • EUDAMED 00859144004005|00859144004524J5 61 fields · synced 25 Oct 2026