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Tempus LS Mount

by Remote Diagnostic Technologies Ltd.

Ref 01-3012/ 989706001111

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

3 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number506047244BM724VB Basic UDI-DI 05060472441423UDI-DIDate6 Sep 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number05060472441423 UDI-DI Date2 Nov 2020ListedStatusListed GUDID: not in commercial distribution

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

4 recalls · 3 ongoing · FDA

    • Ongoing Z-0557-2025 FDA Class III initiated 28 Oct 2024

    Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number.

    • Ongoing Z-2028-2024 FDA Class II initiated 9 May 2024

    Simultaneous ECG measurements with multiple devices, including a manual defibrillator, on the same patient may cause electrical noise or interference, which may lead to distortions of the ECG signal; distortions may lead to no or ineffective pacing, or no or inappropriate defibrillation pulse.

    • Ongoing Z-1825-2023 FDA Class II initiated 8 May 2023

    Defibrillator/pacemaker module (DPM) may encounter a problem causing communication from the Mainboard to the DPM to fail, leading to no or ineffective pacing with displayed error message "HW failure DPM".

    • Terminated Z-0564-2021 FDA Class II initiated 17 Nov 2020

    A software error was detected within software version 1.3.4 for the Tempus LS device. When exiting pacer back into manual mode the pacer pulse wave may put the ECG calibration out of calibration. This software error may result in a delay in therapy, as the clinician is not provided an ECG waveform on which a shockable rhythm decision can be made. The device is still able to deliver a manual defibrillation shock.

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
Tempus LS Mount EUDAMED
Tempus LS-Manual GUDID
Generic Name
Portable active medical device mount
Device Name
Tempus Mounts
Model / Reference
01-3012/ 989706001111 EUDAMED
01-3012 GUDID
Primary DI / UDI-DI
05060472441423
Basic UDI-DI
506047244BM724VB
510(k) Number
FDA Product Code
LDD
EMDN Code
Z1203020299 Multi–parameter monitors - other
GMDN Term
Portable active medical device mount
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
870.5300
EU market of registration
Netherlands
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
01-3012/ 989706001111
GUDID
01-3012
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
GB-MF-000002127
Authorised representative
Philips Medical Systems Nederland B.V. NL-AR-000001422

Other devices from Remote Diagnostic Technologies Limited

See all devices from Remote Diagnostic Technologies Limited →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (21)

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