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Electrolyte 54 905-866

by Radiometer Medical ApS

Ref 905-866

Electrolyte 54 905-866 is a device classified as Class I in the EU and Class II in the US made by Radiometer Medical ApS, registered in EUDAMED on 21 Aug 2026 (Basic UDI-DI 57006900072N2) and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 05700699058669), active as of 24 Oct 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number57006900072N2 Basic UDI-DI 05700699058669UDI-DIDate21 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05700699058669 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 57006900072N2 registered 21 Aug 2026 Active
  • FDA GUDID UDI-DI 05700699058669 listed 1 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05700699058669
  2. Registered EUDAMED 57006900072N2

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  • Withdrawn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
Electrolyte for tc sensor 54 EUDAMED
Electrolyte 54 GUDID
Generic name
Transcutaneous blood gas monitor sensor
Device name
TCM Electrolyte
Model / Ref / Catalog
905-866
Primary DI / UDI-DI
05700699058669
Basic UDI-DI
57006900072N2
Unit of use DI
55700699058664
FDA product code
LKD, LPP, KLK, DPZ, DQA
EMDN code
Z1203020285 Multi-parameter monitors - consumables
GMDN term
Transcutaneous blood gas monitor sensor
Device class
Class I EUDAMED
Class II GUDID
Regulation number
868.2480, 868.2500, 870.2710, 870.2700
EU registration type
Standard device
EU market of registration
Denmark
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: Transcutaneous blood gas monitor sensor

Similar devices in this category

Other devices filed under MULTI-PARAMETER MONITORS - CONSUMABLES.

Other devices from Radiometer Medical ApS

See all devices from Radiometer Medical ApS →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (22, all answered No)