Consulting Wallah › Device Explorer › IVD & laboratory › Haemoglobin analyser IVD, point-of-care
Device Explorer · FDA GUDID · GMDN 32435

Haemoglobin analyser IVD, point-of-care

A mains electricity (AC-powered) instrument, which may include internal rechargeable batteries, intended to be used by health professionals at the point-of-care, and often also in the laboratory, to determine the concentration of haemoglobin in a clinical spec

US‑registered devices51in commercial distribution
Companies6labelers on GUDID
Single‑use49%of device records
Sterile0%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Hemocue Ab1937%
Acon Laboratories, Inc.1122%
Mckesson Medical-Surgical Inc.918%
Ekf-Diagnostic Gmbh816%
Stanbio Laboratory, L.P.36%
Diaspect Medical Gmbh12%

Top labelers

CompanyDevicesShare
Hemocue Ab1937%
Acon Laboratories, Inc.1122%
Mckesson Medical-Surgical Inc.918%
Ekf-Diagnostic Gmbh816%
Stanbio Laboratory, L.P.36%
Diaspect Medical Gmbh12%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

HemoCue® Hb 801 AnalyzerHemoCue® Hb301 AnalyzerHemoCue® Hb 201+ AnalyzerHemoCue® Hb 201 DM AnalyzerHemoCue® Plasma/Low Hb PhotometerAdd Pack Hemo Control DMDiaSpect TmHemo ControlDiaSpect Hemoglobin CuvettesCleanerMission Plus Hemoglobin (Hb) Monitoring SystemMission Plus Hemoglobin (Hb) Optical VerifierMission Plus Hemoglobin (Hb) Test CartridgesMission Plus Hemoglobin (Hb) Control Solution KiMission Capillary Transfer TubesHemoPoint® H2 n•x•t Microcuvettes

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

FDA product codes

CodeNameDevices
GKRSystem, Hemoglobin, Automated38
GKRSYSTEM, HEMOGLOBIN, AUTOMATED10
KHGWhole Blood Hemoglobin Determination8
GGMControl, Hemoglobin3
JJXSingle (specified) analyte controls (assayed and unassayed)1

GMDN & GCC registration

  • GMDN code 32435 · non‑implantable
  • Single‑use 49% · sterile 0% · Rx‑only 100% · 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.

No closely related category with 50+ devices.

How many haemoglobin analyser ivd, point-of-care products are registered in the US?

51 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Haemoglobin analyser IVD, point-of-care", from 6 companies. The largest labeler is Hemocue Ab with 37% of records.

Which FDA product codes apply?

GKR (System, Hemoglobin, Automated), GKR (SYSTEM, HEMOGLOBIN, AUTOMATED), KHG (Whole Blood Hemoglobin Determination), GGM (Control, Hemoglobin)

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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