Skip to content

Unimed MQB5-90XDP-I

by Unimed Medical Supplies, Inc.

Ref MQB5-90XDP-I

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 Number69456648DEC1VD Basic UDI-DI 06936735462476UDI-DIDate19 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06936735462476 UDI-DI Date4 Aug 2022ListedStatusListed 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  • Withdrawn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
Disposable Radiolucent Lead Wires EUDAMED
Unimed GUDID
Generic Name
Electrocardiographic lead set, single-use
Device Name
Disposable ECG Lead Wires
Model / Reference
MQB5-90XDP-I
Primary DI / UDI-DI
06936735462476
Basic UDI-DI
69456648DEC1VD
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
Czechia
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Category: Electrocardiographic lead set, single-use

Cleared under the same submission (K142489)

Show all (12)

Other devices from Unimed Medical Supplies, Inc.

See all devices from Unimed Medical Supplies, Inc. →

Properties

  • Single Use
  • Lot / Batch Number
  • Expiration Date
  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No