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remedē Respistim

by ZOLL Respicardia, Inc. United States EUDAMEDGUDID

Ref 3103

Product code PSREMDN J0206

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/AIMDD EUDAMED NumberB-00857688007070 Basic UDI-DIDate2 Apr 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00857688007070 UDI-DIDate30 Apr 2018ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Listed
  • Not covered
  • European Union CE/AIMDD Expiring (legacy directive)
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 24 Oct 2026

Trade Name
remedē Respistim EUDAMED
respistim R Stimulation Lead GUDID
Generic Name
Transvenous phrenic nerve electrical stimulation control unit
Device Name
remedē Respistim R Stimulation Lead
Model / Reference
3103
Primary DI / UDI-DI
00857688007070
Basic UDI-DI
B-00857688007070
PMA Number
FDA Product Code
PSR
EMDN Code
J0206 Frenic nerve implantable neurostimulators
GMDN Term
Transvenous phrenic nerve electrical stimulation control unit
Device Class
Class AIMDD EUDAMED
Class III GUDID
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class AIMDD
GUDID
Class III
ImplantableEUDAMED
Yes
GUDID
No

Manufacturer details

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

Other devices from ZOLL Respicardia, Inc.

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Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Implantable YesEUDAMEDNoGUDID
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date
Other properties (14)
  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No

Sources (2)

  • EUDAMED 7f88cf2c-bca7-4656-ba60-d17f0f8f34df 61 fields · synced 24 Oct 2026
  • FDA UDI 2f43eed2-5871-42b2-bb6f-cad556c7e3cf 35 fields · synced 30 May 2026