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Multi-LinkTM X2 Single-Patient-Use Direct-Connect Telemetry ECG Leadwire Set 6-Lead Set for Philips, Grabber, AHA

by AirLife Finland Oy

Ref 2090101-513Model Multi-Link X2 Single-Patient-Use Long ECG Leadwire Sets

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

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 Number088948320041cECGmon12XT Basic UDI-DI 10889483577929UDI-DIDate15 May 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10889483577929 UDI-DI Date2 Apr 2025ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
Multi-LinkTM X2 Single-Patient-Use Direct-Connect Telemetry ECG Leadwire Set 6-Lead Set for Philips, Grabber, AHA EUDAMED
Multi-Link™ GUDID
Generic Name
Electrocardiographic lead set, single-use
Model / Ref / Catalog
Multi-Link X2 Single-Patient-Use Long ECG Leadwire Sets, 2090101-513
Primary DI / UDI-DI
10889483577929
Basic UDI-DI
088948320041cECGmon12XT
510(k) Number
FDA Product Code
DSA
EMDN Code
Z12050385 Electrocardiographs - consumables
GMDN Term
Electrocardiographic lead set, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
870.2900
EU market of registration
Finland
GUDID distribution status
In Commercial Distribution
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

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Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • Sterile: 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