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Device Explorer · FDA GUDID · GMDN 47153

Haematological concentrate system preparation kit, bone marrow concentration

A collection of sterile devices typically used at the point-of-care for the rapid preparation of autologous bone marrow aspirate concentrate (BMAC) from bone marrow aspirate. The kit components, with the bone marrow aspirate, are directly placed in a dedicated

US‑registered devices63in commercial distribution
Companies6labelers on GUDID
Single‑use81%of device records
Sterile81%labelled sterile
Prescription67%Rx‑only share
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Share of device records

Emcyte Corp.2032%
Celling Biosciences1829%
Arteriocyte Medical Systems, Inc.1727%
Thermogenesis Corp.46%
Miracell Co., Ltd.35%
Orthoascent, Llc12%

Top labelers

CompanyDevicesShare
Emcyte Corp.2032%
Celling Biosciences1829%
Arteriocyte Medical Systems, Inc.1727%
Thermogenesis Corp.46%
Miracell Co., Ltd.35%
Orthoascent, Llc12%

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

Brand names on the register (sample)

MXP Start Up KitMXP Docking StationMXP DeviceMXP Processing BagsetPureSpin PRP Platelet Concentrating System 60mLPurePRP Supraphysiologic 30mL GenesisCS ComponenAbsoluteBMC 30mL GenesisCS Component ConcentratPurePRP II 30mL GenesisCS Component ConcentratinPurePRP II 120mL GenesisCS Component ConcentratPurePRP II 60mL GenesisCS Component ConcentratiPureBMC-120mL GenesisCS Component Concentrating Accelerate PRP-G 60mL GenesisCS Component ConcenAccelerate II Platelet Concentrating System 60mLAccelerate II Platelet Concentrating System PRP-Accelerate II Bone Marrow Concentrating System 1Cyclone Bone Marrow Concentration System 120mL

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

FDA product codes

CodeNameDevices
JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical Use43
JQCCENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE32
FMFSyringe, piston13
QBVCentrifuge For Preparation Of Cell Concentrate And/Or Plasma3
MQVFiller, Bone Void, Calcium Compound2
ORGPlatelet and plasma separator for bone graft handling1

GMDN & GCC registration

  • GMDN code 47153 · non‑implantable
  • Single‑use 81% · sterile 81% · Rx‑only 67% · 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 haematological concentrate system preparation kit, bone marrow concentration products are registered in the US?

63 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, bone marrow concentration", from 6 companies. The largest labeler is Emcyte Corp. with 32% of records.

Which FDA product codes apply?

JQC (Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use), JQC (CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE), FMF (Syringe, piston), QBV (Centrifuge For Preparation Of Cell Concentrate And/Or Plasma)

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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