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Lifeline ECG DDU-E2450

by Defibtech, L.L.C.

Ref DDU-2450, DDU-E2450Model DDU series - ECG

Lifeline ECG DDU-E2450 is a medical device (EU MDR Class III; FDA Class III; EU MDR Class IIb; FDA product code MKJ, Automated External Defibrillators (Non-Wearable)) made by Defibtech, L.L.C., registered in EUDAMED on 13 Oct 2026 (Basic UDI-DI B-00815098020317) with CE/MDR certificate MDR 781624 valid until 13 Nov 2029, cleared under FDA 510(k) K121853 on 13 Dec 2012 and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 00815098020317), active as of 24 Oct 2026.

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

CE MDR CE MDD 510(k)

Valid until

13 Nov 2029

CE MDR certificate

FDA recalls

None found

in data synced 24 Oct 2026

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

510(k) K121853

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-00815098020317 Basic UDI-DI 00815098020317UDI-DIDate13 Oct 2026RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-00815098020317 Basic UDI-DI 00815098020317UDI-DIDate13 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00815098020317 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK121853 Date13 Dec 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00815098020317 registered 13 Oct 2026 Active· +2 more in the status table
  • FDA 510(k) K121853 decided 13 Dec 2012 Active
  • FDA GUDID UDI-DI 00815098020317 listed 24 Oct 2015 Listed

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

Timeline

5 dated events

  1. Cleared FDA 510(k) K121853
  2. Listed FDA GUDID 00815098020317
  3. Certificate issued EUDAMED MDR 781624
  4. Registered EUDAMED B-00815098020317
  5. Certificate expires EUDAMED MDR 781624

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Defibtech Lifeline ECG EUDAMED
Lifeline ECG GUDID
Generic name
Non-rechargeable professional semi-automated external defibrillator
Device name
DDU-2450 Semi-Automated External Defibrillator
Model / reference
DDU-E2450, DDU-2450, DDU series - ECG
Primary DI / UDI-DI
00815098020317
Basic UDI-DI
B-00815098020317, 081509802DDU24xxBP
510(k) Number
FDA product code
MKJ
EMDN code
Z12030503, Z12030501
GMDN term
Non-rechargeable professional semi-automated external defibrillator
Device class
Class III EUDAMEDGUDID
Class IIb EUDAMED
Regulation number
870.5310
EU registration type
Legacy device (under a directive)
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
Class IIb
GUDID
Class III

Related devices

Category: Non-rechargeable professional semi-automated external defibrillator

Cleared under the same submission (K121853)

and 3 more cleared under K121853

Similar devices in this category

Other devices filed under SEMI-AUTOMATIC DEFIBRILLATORS.

Other devices from Defibtech, L.L.C.

See all devices from Defibtech, L.L.C. →

Properties

  • Serial number
Other properties (24, all answered No)