Data / Medical devices / Labware, Assisted Reproduction, Exempt
Labware, Assisted Reproduction, Exempt (PUD): 23 FDA-registered makers in 8 countries
23 establishments in 8 countries are registered with the FDA to make Labware, Assisted Reproduction, Exempt (product code PUD, Class 2, 21 CFR 884.6160). 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
- PUD
- Device class
- 2
- Regulation
- 884.6160
- Medical specialty
- Obstetrics/Gynecology
Makers by country
Makers of Labware, Assisted Reproduction, 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 |
|---|---|---|---|---|---|---|---|---|
| Accumedix, Inc. | Libertyville, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arck Technologies Innovations Pvt Ltd | Vasai Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ASTEC CO., Ltd. | Kasuya Fukuoka, Japan | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Akita Sumitomo Bakelite Co., Ltd. | Akita, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Birr Biosciences BV | Breukelen Utrecht, Netherlands | 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 | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kanto Gosei Kogyo Co.,ltd. | Sumida-ku Tokyo, Japan | 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 | |
| MFC Global Ltd. | Rishon Le Zion Tel Aviv, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nunc A/S | ROSKILDE Sjaelland, Denmark | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nalge Nunc International Corporation | Rochester, NY, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Omura Kogyo Co., Ltd. Hara Factory | Numazu Shizuoka, Japan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Reprolife Inc. | Shinjuku-ku Tokyo, Japan | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rsi Technology Group, LLC | Frisco, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sparmed Aps | Farum Hovedstaden, Denmark | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Boomingshing Medical Device Co., Ltd | Shenzhen Guangdong, China | 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. | Chongging Sichuan, 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 | |
| Wuhan Huchuang Union Technology Co., Ltd. | Wuhan Hubei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yasui Co., Ltd. | Higashiusuki-gun Miyazaki, Japan | Contract manufacturer, 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.