Consulting Wallah › Device Explorer › Dialysis & renal › Hollow-fibre haemodialysis dialyser, single-use
Device Explorer · FDA GUDID · GMDN 47072

Hollow-fibre haemodialysis dialyser, single-use

A filter that functions as an artificial kidney and typically used in a haemodialysis system to remove impurities/fluid from the blood of a patient. It typically consists of cylindrical containers with thousands of longitudinally arranged hollow-fibre capillar

US‑registered devices90in commercial distribution
Companies11labelers on GUDID
Single‑use100%of device records
Sterile92%labelled sterile
Prescription92%Rx‑only share
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Share of device records

Nipro Medical Corporation2224%
Fresenius Medical Care Holdings, Inc.1618%
Gambro Dialysatoren Gmbh1314%
B.Braun Avitum Ag1213%
Molded Products, Inc.89%
Fresenius Medical Care Ag78%
Bellco Srl56%
Baxter Healthcare Sa33%

Top labelers

CompanyDevicesShare
Nipro Medical Corporation2224%
Fresenius Medical Care Holdings, Inc.1618%
Gambro Dialysatoren Gmbh1314%
B.Braun Avitum Ag1213%
Molded Products, Inc.89%
Fresenius Medical Care Ag78%
Bellco Srl56%
Baxter Healthcare Sa33%
Gambro Renal Products, Inc.22%
Vantive Health Gmbh11%
Mozarc Medical Us Llc11%

Company = labeler of record on GUDID. 11 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

RevaclearREVACLEARTHERANOVAPolyfluxDiacap®xevontamultiFluxFX CorALFX CorAL 1000 DialyzerFX CorAL 800 DialyzerFX CorAL 600 DialyzerFX CorAL 120 DialyzerFX CorAL 100 DialyzerFX CorAL 80 DialyzerFX CorAL 60 DialyzerOptiflux®

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

FDA product codes

CodeNameDevices
KDIDialyzer, high permeability with or without sealed dialysate82
KDIDialyzer, High Permeability With Or Without Sealed Dialysate30
FJIDIALYZER, CAPILLARY, HOLLOW FIBER17
FJIDialyzer, Capillary, Hollow Fiber8
QAXHemodialyzer With Expanded Solute Removal Profile4
QAXHemodialyzer with expanded solute removal profile2

GMDN & GCC registration

  • GMDN code 47072 · non‑implantable
  • Single‑use 100% · sterile 92% · Rx‑only 92% · 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

Area/Surface Area (Square meter) · 58Angle (degree) · 1

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

No closely related category with 50+ devices.

How many hollow-fibre haemodialysis dialyser, single-use products are registered in the US?

90 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Hollow-fibre haemodialysis dialyser, single-use", from 11 companies. The largest labeler is Nipro Medical Corporation with 24% of records.

Which FDA product codes apply?

KDI (Dialyzer, high permeability with or without sealed dialysate), KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate), FJI (DIALYZER, CAPILLARY, HOLLOW FIBER), FJI (Dialyzer, Capillary, Hollow Fiber)

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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