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Device Explorer · FDA GUDID · GMDN 56682

Ion-selective analyser IVD

An electrically-powered automated or semi-automated laboratory instrument intended to be used for the quantitative measurement of electrolytes and/or other ions in a clinical specimen using ion-specific membranes to selectively measure electrical potential aga

US‑registered devices53in commercial distribution
Companies4labelers on GUDID
Single‑use4%of device records
Sterile0%labelled sterile
Prescription81%Rx‑only share
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Share of device records

Diamond Diagnostics Inc.1834%
Roche Diagnostics Gmbh1630%
Medica Corporation1325%
Biobase Biodustry(Shandong)Co., Ltd.611%

Top labelers

CompanyDevicesShare
Diamond Diagnostics Inc.1834%
Roche Diagnostics Gmbh1630%
Medica Corporation1325%
Biobase Biodustry(Shandong)Co., Ltd.611%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

cobas ISE neo 1800 analytical unitSample supply unitcobas pro SBL e 801cobas pro Transport Beltcobas pro Transport Belt (2 AU, 2 ISE)cobas pro SBL c 503cobas pro transport linecobas pro SBcobas pro SSUcobas pro ISE analytical unitcobas pro Sample Supply Unitcobas pro c 503 SBL - DLcobas pro c 503 SBL-TLcobas pro e 801 SBL-DLBIOBASERoche 9180 Electrolyte Analyzer

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
JGSElectrode, Ion Specific, Sodium16
CEMElectrode, Ion Specific, Potassium16
JJEANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL US14
CGZElectrode, Ion-Specific, Chloride10
JIHFlame Photometry, Lithium9
JFPElectrode, Ion Specific, Calcium7

GMDN & GCC registration

  • GMDN code 56682 · non‑implantable
  • Single‑use 4% · sterile 0% · Rx‑only 81% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

How many ion-selective analyser ivd products are registered in the US?

53 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ion-selective analyser IVD", from 4 companies. The largest labeler is Diamond Diagnostics Inc. with 34% of records.

Which FDA product codes apply?

JGS (Electrode, Ion Specific, Sodium), CEM (Electrode, Ion Specific, Potassium), JJE (ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL US), CGZ (Electrode, Ion-Specific, Chloride)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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