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ECG ESIS Leadwires - 5 Lead - Pinch Type - 50" (127cm) – IEC

by Datascope Corp

Ref 0012-00-1814-02Model Cardiosave

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number10607IABPaccessoriesBW Basic UDI-DI 10607567112268UDI-DIDate5 May 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number10607567112268 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
ECG ESIS Leadwires - 5 Lead - Pinch Type - 50" (127cm) – IEC EUDAMED
Cable,ECG LEAD,OR,5L,IEC GUDID
Generic Name
Electrocardiographic lead set, reusable
Device Name
Cardiosave
Model / Ref / Catalog
Cardiosave, 0012-00-1814-02
Primary DI / UDI-DI
10607567112268
Basic UDI-DI
10607IABPaccessoriesBW
FDA Product Code
DSP
EMDN Code
C9080 Cardiocirculatory system devices - accessories not included in other classes
GMDN Term
Electrocardiographic lead set, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
870.3535
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000015587
Authorised representative
MAQUET Critical Care AB SE-AR-000001442

Other devices from Datascope Corp.

See all devices from Datascope Corp. →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (22)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No