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Leadwire

by Advantage Medical Electronics LLC 5 variants

Ref KT-RTR5736

Leadwire (KT-RTR5736) is a device classified as Class I in the EU and Class II in the US made by Advantage Medical Electronics, LLC, registered in EUDAMED on 1 May 2026 (Basic UDI-DI B-00849593018128), cleared under FDA 510(k) K992524 on 1 Mar 2000 and listed in FDA GUDID since 10 Nov 2020 (UDI-DI 00849593018128), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K992524

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00849593018128 Basic UDI-DI 00849593018128UDI-DIDate1 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00849593018128 UDI-DI Date10 Nov 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK992524 Date1 Mar 2000DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00849593018128 registered 1 May 2026 Active
  • FDA 510(k) K992524 decided 1 Mar 2000 Active
  • FDA GUDID UDI-DI 00849593018128 listed 10 Nov 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K992524
  2. Listed FDA GUDID 00849593018128
  3. Registered EUDAMED B-00849593018128

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Leadwire EUDAMED
Amc GUDID
Generic name
Electrocardiographic lead set, reusable
Device name
Radiolucent ECG Leadwires
Model / Ref / Catalog
KT-RTR5736, 590442
Primary DI / UDI-DI
00849593018128
Basic UDI-DI
B-00849593018128
510(k) Number
FDA product code
DSA
EMDN code
C020599, Z12050380
GMDN term
Electrocardiographic lead set, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
870.2900
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
KT-RTR5736
GUDID
590442
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
US-MF-000008512
Authorised representative
Emergo Europe B.V. NL-AR-000000116

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Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)