Data / Medical devices / Microtools, Assisted Reproduction (Pipettes)
Microtools, Assisted Reproduction (Pipettes) (MQH): 12 FDA-registered makers in 7 countries
12 establishments in 7 countries are registered with the FDA to make Microtools, Assisted Reproduction (Pipettes) (product code MQH, Class 2, 21 CFR 884.6130). 8 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 27 510(k) clearances under this code, the latest on October 9, 2026, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MQH
- Device class
- 2
- Regulation
- 884.6130
- Medical specialty
- Obstetrics/Gynecology
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| Canada | 1 |
| China | 1 |
| Germany | 1 |
| Costa Rica | 1 |
| United Kingdom | 1 |
| Greece | 1 |
Makers of Microtools, Assisted Reproduction (Pipettes)
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Coopersurgical, Inc. | Trumbull, CT, United States | Manufacturer, Specification developer | 6 | January 23, 2017 | 0 | 1 | 0 | api.fda.gov |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 5 | January 8, 2016 | 0 | 0 | 0 | api.fda.gov |
| Cook Vandergrift Inc. | Vandergrift, PA, United States | Complaint file establishment, Manufacturer | 4 | January 8, 2016 | 0 | 2 | 0 | api.fda.gov |
| Sunlight Medical, Inc. | Jacksonville, FL, United States | Manufacturer | 2 | April 30, 2010 | 0 | 0 | 0 | api.fda.gov |
| Arsci Inc. | Longueuil Quebec, Canada | Manufacturer | 1 | April 19, 2011 | 0 | 0 | 0 | api.fda.gov |
| Cook Incorporated | Spencer, IN, United States | Manufacturer | 1 | February 5, 1999 | 0 | 0 | 0 | api.fda.gov |
| Guangzhou PINZHI Medical Device Co., Ltd. | Guangzhou Guangdong, China | Exporter to the US, Manufacturer | 1 | July 3, 2025 | 0 | 0 | 0 | api.fda.gov |
| Vitromed GMBH | Jena Thuringia, Germany | Complaint file establishment, Manufacturer | 1 | January 28, 2020 | 0 | 0 | 0 | api.fda.gov |
| Cook Incorporated | Ellettsville, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cooper Medical, SRL | La Garita Alajuela, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Research Instruments Ltd | Falmouth Cornwall, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vitromed SMPC | Ilion Attiki, Greece | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 9, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.