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Device Explorer · FDA GUDID · GMDN 46553

Assisted reproduction microtool

A dedicated pipette or other device used in the laboratory to denude, micromanipulate, hold, or transfer human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods. This is a single-use devic

US‑registered devices913in commercial distribution
Companies12labelers on GUDID
Single‑use99%of device records
Sterile99%labelled sterile
Prescription95%Rx‑only share
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Share of device records

Origio Inc.28932%
Research Instruments Limited24827%
Coopersurgical, Inc.13915%
Astec Bio Usa Inc526%
Arsci Inc.455%
Kitazato Corporation455%
Vitromed Gmbh394%
Hamilton Thorne, Inc.374%

Top labelers

CompanyDevicesShare
Origio Inc.28932%
Research Instruments Limited24827%
Coopersurgical, Inc.13915%
Astec Bio Usa Inc526%
Arsci Inc.455%
Kitazato Corporation455%
Vitromed Gmbh394%
Hamilton Thorne, Inc.374%
Dxnow, Inc.101%
Shenzhen Vitavitro Biotech Co.,Ltd.40%
Fujifilm Irvine Scientific, Inc.30%
Vitrolife Inc.20%

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

Brand names on the register (sample)

MICROTOOLS (Transfer Pipette)MICROTOOLS (Assisted Hatching Pipette)MICROTOOLS (Partial Zona Dissection Pipette)MICROTOOLS (Polar Body Biopsy Pipette)MICROTOOLS (Biopsy Pipette)MICROTOOLS (Denuding Pipette)MICROTOOLS (Holding Pipette)MICROTOOLS (Injection Pipiette)VitaVitroEZ-SqueezeEZ-TipEZ-StripRI PipettesKitazato Injection MicropipetteKitazato Holding MicropipetteKitazato Partial Zona Dissection Micropipette

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

FDA product codes

CodeNameDevices
MQHMicrotools, Assisted Reproduction (Pipettes)394
MQHMICROTOOLS, ASSISTED REPRODUCTION (PIPETTES)248
PUCMicrotools, Assisted Reproduction (Pipettes), Exempt216
PUCMicrotools, assisted reproduction (pipettes), exempt43
MQJMICROMANIPULATORS AND MICROINJECTORS, ASSISTED REPRODUCTION20
MQKLabware, Assisted Reproduction11

GMDN & GCC registration

  • GMDN code 46553 · non‑implantable
  • Single‑use 99% · sterile 99% · Rx‑only 95% · 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

Lumen/Inner Diameter (Micrometer) · 258Angle (degree) · 20Outer Diameter (Micrometer) · 7Total Volume (Milliliter) · 5Length (Millimeter) · 2

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

How many assisted reproduction microtool products are registered in the US?

913 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Assisted reproduction microtool", from 12 companies. The largest labeler is Origio Inc. with 32% of records.

Which FDA product codes apply?

MQH (Microtools, Assisted Reproduction (Pipettes)), MQH (MICROTOOLS, ASSISTED REPRODUCTION (PIPETTES)), PUC (Microtools, Assisted Reproduction (Pipettes), Exempt), PUC (Microtools, assisted reproduction (pipettes), exempt)

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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