Device Explorer · FDA GUDID · GMDN 42850

IVF medium kit

A collection of solutions used to provide a physiological environment for the retrieval, culture, maintenance, transfer, and/or storage of human sperm, harvested oocytes (eggs), and/or resulting embryos associated with the method of in vitro fertilization (IVF

US‑registered devices153in commercial distribution
Companies9labelers on GUDID
Single‑use87%of device records
Sterile100%labelled sterile
Prescription70%Rx‑only share
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Share of device records

Kitazato Corporation7650%
Coopersurgical, Inc.2013%
Origio A/S1711%
Gimbo Medical Technology Shenzhen Co., Ltd.117%
Vitrolife Sweden Ab107%
Fujifilm Irvine Scientific, Inc.107%
Experimental Culture Media Productions And Consignment Llc32%
William A. Cook Australia Pty. Ltd.32%

Top labelers

CompanyDevicesShare
Kitazato Corporation7650%
Coopersurgical, Inc.2013%
Origio A/S1711%
Gimbo Medical Technology Shenzhen Co., Ltd.117%
Vitrolife Sweden Ab107%
Fujifilm Irvine Scientific, Inc.107%
Experimental Culture Media Productions And Consignment Llc32%
William A. Cook Australia Pty. Ltd.32%
Lifeglobal Group, Llc32%

Company = labeler of record on GUDID. 9 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

RapidWarm OocyteRapidVit OocyteRapidWarm BlastRapidVit BlastThawKit CleaveFreezeKit CleaveRapidWarm CleaveRapidVit CleaveG-Vitri™ Warming mediaG-Vitri™ Vitrification mediaThawing Media (WS solution)Thawing Media (DS solution)Thawing Media (TS solution)Vitrification Media(VS solution)Vitrification Media(ES solution)Vitrification Media(BS solution)

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

FDA product codes

CodeNameDevices
MQLMedia, Reproductive96
MQLMEDIA, REPRODUCTIVE86
PUDLabware, assisted reproduction, exempt8
MQKLABWARE, ASSISTED REPRODUCTION2

GMDN & GCC registration

  • GMDN code 42850 · non‑implantable
  • Single‑use 87% · sterile 100% · Rx‑only 70% · OTC 7%
  • 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) · 9

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

No closely related category with 50+ devices.

How many ivf medium kit products are registered in the US?

153 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "IVF medium kit", from 9 companies. The largest labeler is Kitazato Corporation with 50% of records.

Which FDA product codes apply?

MQL (Media, Reproductive), MQL (MEDIA, REPRODUCTIVE), PUD (Labware, assisted reproduction, exempt), MQK (LABWARE, ASSISTED REPRODUCTION)

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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