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Carotid Sinus Lead Repair Kit

by CVRx, Inc. United States EUDAMED

Ref 100056-201Model 5010 EMDN J0280

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/AIMDD NumberB-00859144004173 Basic UDI-DIDate7 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/AIMDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
5010, 100056-201
Primary DI / UDI-DI
00859144004173
Basic UDI-DI
B-00859144004173
EMDN Code
J0280 Implantable neurostimulators - accessories
Device Class
Class AIMDD
Market of Registration
Germany

Manufacturer details

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

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Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
Other properties (9)
  • 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 e64c9113-2e45-437a-9145-da30025909bc 61 fields · synced 24 Oct 2026