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Device Explorer · FDA GUDID · GMDN 44290

Assisted reproduction heater/incubator

An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and pr

US‑registered devices65in commercial distribution
Companies10labelers on GUDID
Single‑use0%of device records
Sterile2%labelled sterile
Prescription52%Rx‑only share
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Share of device records

Thermo Fisher Scientific (Asheville) Llc1625%
Research Instruments Limited1320%
Planer Limited1320%
Esco Medical Technologies Uab69%
Coopersurgical, Inc.69%
Hua Yue Medical Technology Co., Ltd.46%
Astec Co.,Ltd.23%
William A. Cook Australia Pty. Ltd.23%

Top labelers

CompanyDevicesShare
Thermo Fisher Scientific (Asheville) Llc1625%
Research Instruments Limited1320%
Planer Limited1320%
Esco Medical Technologies Uab69%
Coopersurgical, Inc.69%
Hua Yue Medical Technology Co., Ltd.46%
Astec Co.,Ltd.23%
William A. Cook Australia Pty. Ltd.23%
Thermo Electron Led Gmbh23%
Genea Biomedx Pty Ltd12%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

HARIOMEDK-SystemsG210 InviCell Plus IncubatorG210 InviCell Standard IncubatorG185CODAMultiroom IVF incubatorMultiroom IVF incubatorEC10-120MDDry IncubatorCOOKCookCT37 IncubatorBT37 IncubatorBT37Thermo Scientific

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

FDA product codes

CodeNameDevices
PUBAccessory, Assisted Reproduction, Exempt40
MQGAccessory, Assisted Reproduction24
MQGAccessory, assisted reproduction1
MQGACCESSORY, ASSISTED REPRODUCTION1
MQKLabware, Assisted Reproduction1
MTXMicroscope And Microscope Accessories,Reproduction,Assisted1

GMDN & GCC registration

  • GMDN code 44290 · non‑implantable
  • Single‑use 0% · sterile 2% · Rx‑only 52% · OTC 2%
  • 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.

How many assisted reproduction heater/incubator products are registered in the US?

65 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Assisted reproduction heater/incubator", from 10 companies. The largest labeler is Thermo Fisher Scientific (Asheville) Llc with 25% of records.

Which FDA product codes apply?

PUB (Accessory, Assisted Reproduction, Exempt), MQG (Accessory, Assisted Reproduction), MQG (Accessory, assisted reproduction), MQG (ACCESSORY, 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.

How do I get quotes?

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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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