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DDU-29XX series, universal pad, single pair DDP-2004

by Defibtech, L.L.C.

Ref DDP-2004Model DDU series

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

CE MDR

Valid until

13 Nov 2029

CE MDR certificate

FDA recalls

9 ongoing

This device is named in the recall

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberMDR 781624 Date21 Sep 2026IssuedStatusActive expires 13 Nov 2029
United StatesGUDID listing GUDID Number00815098021550 UDI-DI Date9 Dec 2025ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 781624 Active Supplemented

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    21 Sep 2026
    Expires
    13 Nov 2029
    Reason
    Add device or group

Recalls

9 recalls · 9 ongoing · FDA

  • 5 recalls, same reason

    • Ongoing Z-1691-2025 FDA Class II initiated 18 Mar 2025
    • Ongoing Z-1690-2025 FDA Class II initiated 18 Mar 2025
    • Ongoing Z-1692-2025 FDA Class II initiated 18 Mar 2025
    • Ongoing Z-1693-2025 FDA Class II initiated 18 Mar 2025
    • Ongoing Z-1694-2025 FDA Class II initiated 18 Mar 2025

    It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian).

  • 3 recalls, same reason

    • Ongoing Z-0505-2025 FDA Class II initiated 14 Oct 2024
    • Ongoing Z-0504-2025 FDA Class II initiated 14 Oct 2024
    • Ongoing Z-0503-2025 FDA Class II initiated 14 Oct 2024

    Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could potentially lead to expired Defibtech AED Pads appearing as though they are within the acceptable shelf life.there is a possibility of hydrogel drying, which may result in poor electrical connection to the patient, which can reduce the energy delivered to the patient

    • Ongoing Z-0502-2025 FDA Class II initiated 14 Oct 2024

    Within the Irish Market, a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could lead to expired Defibtech AED Pads appearing as though they are within the acceptable shelf life. There is a possibility of hydrogel drying, which may result in poor electrical connection to the patient, which can reduce the energy delivered to the patient.

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
Defibtech Pads, DDU-29XX series, universal pad EUDAMED
DDU-29XX series, universal pad, single pair GUDID
Generic Name
External defibrillation electrode, adult, single-use
Model / Reference
DDP-2004, DDU series
Primary DI / UDI-DI
00815098021550
Basic UDI-DI
081509802DDUE3
PMA Number
FDA Product Code
MKJ
EMDN Code
Z12030585 Defibrillators - consumables
GMDN Term
External defibrillation electrode, adult, single-use
Device Class
Class III
Regulation Number
870.5310
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (P160032)

Show all (12)

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Properties

  • Single Use
  • Lot / Batch Number
  • Expiration Date

Other properties (21)

  • 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
  • Manufacturing Date: No