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remede Respistim

by ZOLL Respicardia, Inc. United States EUDAMED

Ref 3101, N/A, 4085, 4045, 3106, 3105, 3206, 3205, 4055, 3202, 3204, 3104, 3203

EMDN J0206

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/AIMDD NumberB-00857688007056 Basic UDI-DIDate1 Apr 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/AIMDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Trade Name
remede Respistim
remede
remedē Respistim
Device Name
remedē Respistim R Stimulation Lead
remede Programmer Power Supply and USB cable
remedē Respistim LQS Stimulation Lead
Model / Reference
3101, N/A, 4085, 4045, 3106, 3105, 3206, 3205, 4055, 3202, 3204, 3104, 3203
Primary DI / UDI-DI
00857688007056, 00857688007353, 00857688007247, 00857688007216, 00857688007100, 00857688007094, 00857688007162, 00857688007155, 00857688007223, 00857688007124, 00857688007148, 00857688007087, 00857688007131
Basic UDI-DI
B-00857688007056, B-00857688007353, B-00857688007247, B-00857688007216, B-00857688007100, B-00857688007094, B-00857688007162, B-00857688007155, B-00857688007223, B-00857688007124, B-00857688007148, B-00857688007087, B-00857688007131
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 YesEUDAMEDNoEUDAMED
  • Implantable YesEUDAMEDNoEUDAMED
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 (13)

  • EUDAMED 19a54b55-f275-4b44-8c18-54e3489f3568 61 fields · synced 24 Oct 2026
  • EUDAMED 00857688007353|B-00857688007353 61 fields · synced 16 May 2026
  • EUDAMED 00857688007247|B-00857688007247 61 fields · synced 16 May 2026
  • EUDAMED 00857688007216|B-00857688007216 61 fields · synced 16 May 2026
  • EUDAMED 00857688007100|B-00857688007100 61 fields · synced 16 May 2026
  • EUDAMED 00857688007094|B-00857688007094 61 fields · synced 17 May 2026
  • EUDAMED 00857688007162|B-00857688007162 61 fields · synced 17 May 2026
  • EUDAMED 00857688007155|B-00857688007155 61 fields · synced 17 May 2026
  • EUDAMED 00857688007223|B-00857688007223 61 fields · synced 18 May 2026
  • EUDAMED 00857688007124|B-00857688007124 61 fields · synced 18 May 2026
  • EUDAMED 00857688007148|B-00857688007148 61 fields · synced 18 May 2026
  • EUDAMED 00857688007087|B-00857688007087 61 fields · synced 18 May 2026
  • EUDAMED 00857688007131|B-00857688007131 61 fields · synced 19 May 2026