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Device Explorer · FDA GUDID · GMDN 46923

Haematological concentrate system preparation kit, platelet concentration

A collection of devices designed to prepare platelet-rich plasma (PRP) or platelet-rich fibrin matrix (PRFM) from an autologous blood specimen for application to soft-tissue wounds and injured bone to accelerate healing and/or achieve haemostasis. It includes

US‑registered devices281in commercial distribution
Companies28labelers on GUDID
Single‑use100%of device records
Sterile94%labelled sterile
Prescription74%Rx‑only share
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Share of device records

Ranfac Corp.3111%
Aeon Biotherapeutics Corp.3011%
Arteriocyte Medical Systems, Inc.2910%
Regen Lab Sa249%
Estar Technologies Ltd197%
Exocube Biyoteknoloji Anonim Sirketi197%
Apex Biologix , Llc186%
Emcyte Corp.145%

Top labelers

CompanyDevicesShare
Ranfac Corp.3111%
Aeon Biotherapeutics Corp.3011%
Arteriocyte Medical Systems, Inc.2910%
Regen Lab Sa249%
Estar Technologies Ltd197%
Exocube Biyoteknoloji Anonim Sirketi197%
Apex Biologix , Llc186%
Emcyte Corp.145%
Biotechnology Institute Sl145%
Arthrex, Inc.135%
Celling Biosciences124%
Royal Biologics Inc.93%

Company = labeler of record on GUDID. 28 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Tropocells®, Eclipse PRP, Healeon PRPCellenis®TropocellsEclipse PRP, TropocellsTropoCellsTROPOCELLSBox - 3C Patch® Kit4 x (21G Needle + 3C Patch® Needle Holder)3C Patch® Kit3C Patch® Device3C Patch® Needle HolderVirtue ACKitTranscend PRPVirtue CPKitAeon ACKitAeon CPKit

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 Handling178
ORGPlatelet and plasma separator for bone graft handling27
JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical Use20
PMQPeripheral Blood Processing Device For Wound Management13
FMFSyringe, Piston13
GIOTube, Collection, Capillary Blood12

GMDN & GCC registration

  • GMDN code 46923 · non‑implantable
  • Single‑use 100% · sterile 94% · Rx‑only 74% · 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

Total Volume (Milliliter) · 55

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

No closely related category with 50+ devices.

How many haematological concentrate system preparation kit, platelet concentration products are registered in the US?

281 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Haematological concentrate system preparation kit, platelet concentration", from 28 companies. The largest labeler is Ranfac Corp. with 11% of records.

Which FDA product codes apply?

ORG (Platelet And Plasma Separator For Bone Graft Handling), ORG (Platelet and plasma separator for bone graft handling), JQC (Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use), PMQ (Peripheral Blood Processing Device For Wound Management)

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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