Data / Medical devices / Micromanipulators And Microinjectors, Assisted Reproduction
Micromanipulators And Microinjectors, Assisted Reproduction (MQJ): 10 FDA-registered makers in 6 countries
10 establishments in 6 countries are registered with the FDA to make Micromanipulators And Microinjectors, Assisted Reproduction (product code MQJ, Class 2, 21 CFR 884.6150). 2 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 23 510(k) clearances under this code, the latest on January 23, 2015, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MQJ
- Device class
- 2
- Regulation
- 884.6150
- Medical specialty
- Obstetrics/Gynecology
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| China | 3 |
| Japan | 1 |
| United Kingdom | 1 |
| Germany | 1 |
| Denmark | 1 |
Makers of Micromanipulators And Microinjectors, Assisted Reproduction
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 |
|---|---|---|---|---|---|---|---|---|
| Narishige Lifemed Co., Ltd | Tokyo, Japan | Manufacturer | 7 | June 20, 2012 | 0 | 0 | 0 | api.fda.gov |
| Research Instruments Ltd | Falmouth Cornwall, United Kingdom | Manufacturer | 1 | November 22, 2000 | 0 | 1 | 0 | api.fda.gov |
| Allwin Medical Devices, Inc. | Anaheim, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biozol Diagnostica Vertrieb GMBH | Hamburg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cook Incorporated | Spencer, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou PINZHI Medical Device Co., Ltd. | Guangzhou Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HAMILTON THORNE, Inc. | Beverly, MA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hua Yue Medical Technology Co., Ltd. | Guangzhou Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sparmed Aps | Farum Hovedstaden, Denmark | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wuhan Huchuang Union Technology Co., Ltd. | Wuhan Hubei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 23, 2015. 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.