# Lifeline ECG DDU-E2450

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/lifeline-ecg-ddu-e2450>
- Manufacturer: [Defibtech, L.L.C.](https://devicerts.com/manufacturers/defibtech-l-l-c) (United States)
- Device class: Class III (EU MDR / EU MDD / US FDA); Class IIb (EU MDR / EU MDD)
- FDA product code: MKJ
- EMDN: Z12030503 AUTOMATIC DEFIBRILLATORS
- EMDN: Z12030501 SEMI-AUTOMATIC DEFIBRILLATORS
- GMDN: Non-rechargeable professional semi-automated external defibrillator (48049)

## Registrations and authorizations

- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI B-00815098020317 · UDI-DI 00815098020317 · registered 2026-10-13 · status: Active
- **EUDAMED** · CE/MDD · European Union · Basic UDI-DI B-00815098020317 · UDI-DI 00815098020317 · registered 2026-10-13 · status: Active
- **EUDAMED** · CE/MDR · European Union · MDR 781624 · issued 2026-09-21 · expires 2029-11-13 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 00815098020317 · listed 2015-10-24 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K121853 · decision 2012-12-13 · decision SESE · status: Active · from GUDID

## EU certificates

- MDR 781624 · Technical documentation · MDR · notified body BSI Group The Netherlands B.V. · issued 2026-09-21 · expires 2029-11-13 · status: supplemented

## Recalls

No recall on record.

## Identity

- Trade name: Defibtech Lifeline ECG [EUDAMED]; Lifeline ECG [FDA GUDID (AccessGUDID)]
- Generic name: Non-rechargeable professional semi-automated external defibrillator [FDA GUDID (AccessGUDID)]
- Device name: DDU-2450 Semi-Automated External Defibrillator [EUDAMED]
- Model / reference: DDU-E2450 [EUDAMED, FDA GUDID (AccessGUDID)]; DDU-2450 [EUDAMED]; DDU series - ECG [EUDAMED]

## Identifiers

- Primary DI / UDI-DI: 00815098020317 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: B-00815098020317 [EUDAMED]; 081509802DDU24xxBP [EUDAMED]
- 510(k) Number: K121853 [FDA GUDID (AccessGUDID)]
- FDA product code: MKJ [FDA GUDID (AccessGUDID)]
- EMDN code: Z12030503 [EUDAMED]; Z12030501 [EUDAMED]
- GMDN term: Non-rechargeable professional semi-automated external defibrillator (48049) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class III [EUDAMED, FDA GUDID (AccessGUDID)]; Class IIb [EUDAMED]
- Regulation number: 870.5310 [FDA GUDID (AccessGUDID)]
- EU registration type: Legacy device (under a directive) [EUDAMED]; Standard device [EUDAMED]
- EU market of registration: Netherlands [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Prescription use: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Lot / batch number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Lifeline ECG DDU-E2450, Defibtech, L.L.C. deviCERTS medical device catalogue. https://devicerts.com/devices/lifeline-ecg-ddu-e2450 (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-10-24
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/lifeline-ecg-ddu-e2450.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/lifeline-ecg-ddu-e2450
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.