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5 Lead (AHA) Radiolucent Lead wire set, ML, grabber, 5x120 cm

by Fysicon B.V.

Ref 01077302

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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08720938410185 UDI-DI Date19 May 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number8719689142QMAPPCONSKJ Basic UDI-DI 08720938410185UDI-DIDate16 May 2023RegisteredStatusActive

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 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  • Withdrawn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
5 Lead (AHA) Radiolucent Lead wire set, ML, grabber, 5x120 cm EUDAMED
Qmapp GUDID
Generic Name
Multiple physiological parameter monitoring support kit
Device Name
QMAPP Consumables
Model / Ref / Catalog
01077302, 5 Lead (AHA) Radiolucent Lead wire set, ML, grabber, 5x120 cm
Primary DI / UDI-DI
08720938410185
Basic UDI-DI
8719689142QMAPPCONSKJ
510(k) Number
FDA Product Code
DSA
EMDN Code
Z12050785 Instruments for cardiological polygraphy - consumables
GMDN Term
Multiple physiological parameter monitoring support kit
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
870.2900
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
01077302
GUDID
5 Lead (AHA) Radiolucent Lead wire set, ML, grabber, 5x120 cm
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
NL-MF-000002694

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Properties

  • Lot / Batch Number
  • Manufacturing Date

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