Data / Medical devices / Microtools, Assisted Reproduction (Pipettes), Exempt
Microtools, Assisted Reproduction (Pipettes), Exempt (PUC): 18 FDA-registered makers in 9 countries
18 establishments in 9 countries are registered with the FDA to make Microtools, Assisted Reproduction (Pipettes), Exempt (product code PUC, Class 2, 21 CFR 884.6130). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PUC
- Device class
- 2
- Regulation
- 884.6130
- Medical specialty
- Obstetrics/Gynecology
Makers by country
| Country | Makers |
|---|---|
| China | 7 |
| United States | 4 |
| Costa Rica | 1 |
| United Kingdom | 1 |
| Japan | 1 |
| Monaco | 1 |
| Sweden | 1 |
| Germany | 1 |
| Greece | 1 |
Makers of Microtools, Assisted Reproduction (Pipettes), Exempt
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 |
|---|---|---|---|---|---|---|---|---|
| Arsci Biomedical Inc. | Jiaxing Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cook Vandergrift Inc. | Vandergrift, PA, United States | Complaint file establishment, 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 | |
| Coopersurgical, Inc. | Trumbull, CT, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Donnevie Medical Technology (shanghai) Co.ltd | Shanghai, China | 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 | |
| Hunter Scientific Ltd | Saffron Walden Essex, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Kangjian Medical Apparatus Co., Ltd. | JIANGYAN Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kitazato Corporation | Fuji Shizuoka, Japan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Promepla S.A.M | MONACO Monaco-Ville, Monaco | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen VitaVitro Biotech Co.,Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| UKS Medical Technology (Chongqing) Co., Ltd. | Chongqing, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vitrolife Sweden AB | Vastra Frolunda Vastra Gotaland, Sweden | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vitromed GMBH | Jena Thuringia, Germany | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vitromed SMPC | Ilion Attiki, Greece | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vitrolife Inc. | San Diego, CA, United States | Contract 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 November 2, 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.