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Vital Signs™ 300-Series ECG Leadwire, 5-lead, Grabber, IEC, 125 cm/ 49 in & 75 cm/ 30 in

by AirLife Finland Oy 2 variants

Ref 545316-HEL

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0190752TDHEL139PG Basic UDI-DI 10190752181144UDI-DIDate14 Dec 2021RegisteredStatusActive
United StatesGUDID listing GUDID Number10190752181144 UDI-DI Date2 Apr 2021ListedStatusListed 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  • Withdrawn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
Vital Signs™ 300-Series ECG Leadwire, 5-lead, Grabber, IEC, 125 cm/ 49 in & 75 cm/ 30 in EUDAMED
Vital Signs™ GUDID
Generic Name
Electrocardiographic lead set, reusable
Device Name
Vital Signs™ 300-Series ECG Leadwire
Model / Ref / Catalog
545316-HEL
Primary DI / UDI-DI
10190752181144
Basic UDI-DI
0190752TDHEL139PG
Direct Marketing DI
10190752181144
FDA Product Code
DSA
EMDN Code
Z12050380 Electrocardiographs - hardware accessories
GMDN Term
Electrocardiographic lead set, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
870.2900
EU market of registration
Finland
GUDID distribution status
In Commercial Distribution
Sterilization Method
High-level Disinfectant
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
FI-MF-000001482

Related devices

Category: Electrocardiographic lead set, reusable

Other devices from AirLife Finland Oy

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Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • 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