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Electrode for ABL analyzers 945-663

by Radiometer Medical ApS

Electrode for ABL analyzers 945-663 is a Class II device made by Radiometer Medical ApS, listed in FDA GUDID since 1 Sep 2016 (UDI-DI 05700699456632), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05700699456632 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Electrode for ABL analyzers
Generic name
Creatinine IVD, reagent
Model / Ref / Catalog
945-663
Primary DI / UDI-DI
05700699456632
FDA product code
CGL, CGA, KQI, CGZ, CIG, CEM, KHP, GHS, MQM, JFP, JGS, CHL
GMDN term
Creatinine IVD, reagent
Device class
Class II
Regulation number
862.1225, 862.1345, 864.7455, 862.1170, 862.1110, 862.1600, 862.1450, 864.7425, 862.1113, 862.1145, 862.1665, 862.1120
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code CGL (ELECTRODE, ION BASED, ENZYMATIC, CREATININE).

Other devices from Radiometer Medical ApS

See all devices from Radiometer Medical ApS →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)