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remedē Respistim

by ZOLL Respicardia, Inc. United States EUDAMED

Ref 3201

EMDN J0206

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-00857688007117 Basic UDI-DIDate2 Apr 2025RegisteredStatusActive

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
remedē Respistim R Stimulation Lead
Model / Reference
3201
Primary DI / UDI-DI
00857688007117
Basic UDI-DI
B-00857688007117
EMDN Code
J0206 Frenic nerve implantable neurostimulators
Device Class
Class AIMDD
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000023953
Authorised representative
ICON (LR) Limited IE-AR-000006507

Other devices from ZOLL Respicardia, Inc.

See all devices from ZOLL Respicardia, Inc. →

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 7bfd1902-3a20-4437-a051-2518e6813ad4 61 fields · synced 22 Oct 2026