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NMT Thermistor Trident MS15053

by Draeger Medical Systems, Inc.

Ref MS15053Model 1070276K19Z540

NMT Thermistor Trident MS15053 is a general-purpose patient temperature probe (EU MDR Class I; FDA Class II; FDA product code DSA, Cable, Transducer And Electrode, Patient, (Including Connector)) made by Draeger Medical Systems, Inc., registered in EUDAMED on 27 May 2026 (Basic UDI-DI 0404867521070276K19Z540UR), cleared under FDA 510(k) K042003 on 1 Sep 2004 and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 04049098006026), active as of 23 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K042003

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0404867521070276K19Z540UR Basic UDI-DI 04049098006026UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04049098006026 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK042003 Date1 Sep 2004DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0404867521070276K19Z540UR registered 27 May 2026 Active
  • FDA 510(k) K042003 decided 1 Sep 2004 Active
  • FDA GUDID UDI-DI 04049098006026 listed 24 Oct 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K042003
  2. Listed FDA GUDID 04049098006026
  3. Registered EUDAMED 0404867521070276K19Z540UR

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Nmt-Thermistor Trident EUDAMED
NMT Thermistor Trident GUDID
Generic name
General-purpose patient temperature probe, reusable
Model / reference
MS15053, 1070276K19Z540
Primary DI / UDI-DI
04049098006026
Basic UDI-DI
0404867521070276K19Z540UR
510(k) Number
FDA product code
DSA
EMDN code
Z120622 Muscle stimulators
GMDN term
General-purpose patient temperature probe, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
870.2900
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: General-purpose patient temperature probe, reusable

Cleared under the same submission (K042003)

Similar devices in this category

Other devices filed under MUSCLE STIMULATORS.

Other devices from Draeger Medical Systems, Inc.

See all devices from Draeger Medical Systems, Inc. →

Properties

  • Manufacturing date
Other properties (24, all answered No)