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Device Explorer · FDA GUDID · GMDN 47183

Haematological concentrate system

An assembly of devices typically used at the point-of-care to concentrate platelets or bone marrow aspirate cells, through low-speed centrifugal force (e.g., 2,500 to 7,000 rpm), from a small volume of a patient's own blood/bone marrow for the rapid preparatio

US‑registered devices74in commercial distribution
Companies11labelers on GUDID
Single‑use65%of device records
Sterile64%labelled sterile
Prescription93%Rx‑only share
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Share of device records

Intra-Lock International, Inc.1824%
Bimini Technologies Llc1216%
Biomet Biologics, Llc1115%
Biohorizons Implant Systems, Inc1014%
Eclipse79%
Bahia Medical Inc.57%
Dsm Biomedical, Inc.45%
Alliance Partners Llc34%

Top labelers

CompanyDevicesShare
Intra-Lock International, Inc.1824%
Bimini Technologies Llc1216%
Biomet Biologics, Llc1115%
Biohorizons Implant Systems, Inc1014%
Eclipse79%
Bahia Medical Inc.57%
Dsm Biomedical, Inc.45%
Alliance Partners Llc34%
Rmedica Co.,Ltd23%
Gale Force Aesthetics, Llc11%
Orthoascent, Llc11%

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

Brand names on the register (sample)

GPS® III PLATELET CONCENTRATION SYSTEMGPS® III Platelet Concentration SystemBioCUE® Concentration SystemBioCUE® Mini Concentration SystemBioCUE®GPS®III Mini Platelet Concentration SystemGPS® IIIIlluminate PRPQigenix PRPEclipse PRP HCEclipse PRPGenesisGoldrushMARGENIXGold Rush PRPGENESIS PRP 30mL Concentrating System

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

FDA product codes

CodeNameDevices
ORGPlatelet And Plasma Separator For Bone Graft Handling54
GIOTube, Collection, Capillary Blood13
KSSSUPPLIES, BLOOD-BANK7
JQCCENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE4
NDPAccessories, Implant, Dental, Endosseous4
ORGPlatelet and plasma separator for bone graft handling3

GMDN & GCC registration

  • GMDN code 47183 · non‑implantable
  • Single‑use 65% · sterile 64% · Rx‑only 93% · 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

Weight (Gram) · 6Depth (Inch) · 6Width (Inch) · 6Height (Inch) · 6Total Volume (Milliliter) · 4Total Volume (Microliter) · 2

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

No closely related category with 50+ devices.

How many haematological concentrate system products are registered in the US?

74 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Haematological concentrate system", from 11 companies. The largest labeler is Intra-Lock International, Inc. with 24% of records.

Which FDA product codes apply?

ORG (Platelet And Plasma Separator For Bone Graft Handling), GIO (Tube, Collection, Capillary Blood), KSS (SUPPLIES, BLOOD-BANK), JQC (CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE)

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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