Data / Medical devices / Colposcope (And Colpomicroscope)
Colposcope (And Colpomicroscope) (HEX): 14 FDA-registered makers in 6 countries
14 establishments in 6 countries are registered with the FDA to make Colposcope (And Colpomicroscope) (product code HEX, Class 2, 21 CFR 884.1630). 11 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 56 510(k) clearances under this code, the latest on June 14, 2024, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HEX
- Device class
- 2
- Regulation
- 884.1630
- Medical specialty
- Obstetrics/Gynecology
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| China | 4 |
| Argentina | 1 |
| Israel | 1 |
| Germany | 1 |
| South Korea | 1 |
Makers of Colposcope (And Colpomicroscope)
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, Repackager or relabeler | 3 | October 23, 2014 | 0 | 0 | 0 | api.fda.gov |
| Lutech Industries | Indianapolis, IN, United States | Manufacturer, Repackager or relabeler | 2 | May 21, 2017 | 0 | 0 | 0 | api.fda.gov |
| Medgyn Products, Inc. | Westmont, IL, United States | Manufacturer, Specification developer | 2 | June 12, 2013 | 0 | 0 | 0 | api.fda.gov |
| Alltion (Guangxi) Instrument Co., Ltd. | Wuzhou City Guangxi, China | Manufacturer | 1 | August 7, 2006 | 0 | 0 | 0 | api.fda.gov |
| Beijing Tech Instrument Co., Ltd. | Chongwen District Beijing, China | Manufacturer | 1 | November 15, 2007 | 0 | 0 | 0 | api.fda.gov |
| Calla Health Foundation | Durham, NC, United States | Complaint file establishment, Specification developer | 1 | September 21, 2018 | 0 | 0 | 0 | api.fda.gov |
| Ecleris SRL | Villa Martelli Buenos Aires, Argentina | Manufacturer | 1 | July 9, 2010 | 0 | 0 | 0 | api.fda.gov |
| Illumigyn Ltd. | Neve Ilan Central, Israel | Manufacturer | 1 | May 8, 2019 | 0 | 0 | 0 | api.fda.gov |
| Leisegang Feinmechanik-Optik GMBH | Berlin, Germany | Manufacturer | 1 | October 23, 2014 | 0 | 0 | 0 | api.fda.gov |
| Seiler Instrument & Mfg. Co.,Inc. | Saint Louis, MO, United States | Manufacturer | 1 | August 6, 2010 | 0 | 0 | 0 | api.fda.gov |
| Xuzhou Kernel Medical Equipment Co Ltd | Xuzhou Jiangsu, China | Manufacturer | 1 | September 14, 2016 | 0 | 0 | 0 | api.fda.gov |
| B'orze Inc | Boise, ID, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bistos co., ltd. | Yongin-si Gyeonggi, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Goldcare Meditech Co., Ltd. | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 14, 2024. 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.