Data / Medical devices / Microscope And Microscope Accessories, Reproduction, Assisted
Microscope And Microscope Accessories, Reproduction, Assisted (MTX): 14 FDA-registered makers in 7 countries
14 establishments in 7 countries are registered with the FDA to make Microscope And Microscope Accessories, Reproduction, Assisted (product code MTX, Class 1, 21 CFR 884.6190). 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 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MTX
- Device class
- 1
- Regulation
- 884.6190
- Medical specialty
- Obstetrics/Gynecology
Makers by country
| Country | Makers |
|---|---|
| Japan | 5 |
| China | 3 |
| India | 2 |
| Germany | 1 |
| Australia | 1 |
| Thailand | 1 |
| Denmark | 1 |
Makers of Microscope And Microscope Accessories, Reproduction, Assisted
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 |
|---|---|---|---|---|---|---|---|---|
| Appasamy Associates Private Limited ( Thruvandar Koil) | Mannadipet Commune Puducherry, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Appasamy Associates Private Limited (MN Kuppam) | Villupuram District Tamil Nadu, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cohen Industry Co., Ltd. | Kitakata Fukushima, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carl Zeiss Microscopy, GmbH | Jena Thuringia, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carl Zeiss Suzhou Co., Ltd. | Suzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Evident Corporation | Kamiina-gun Nagano, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Evident Corporation | Hachioji-shi Tokyo, Japan | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Evident Nagano Corporation | Kamiina-gun Nagano, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GENEA BIOMEDX Pty Ltd. | Sydney New South Wales, Australia | 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 | |
| Nikon Corporation | SHINAGAWA-KU Tokyo, Japan | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plexus (Thailand) Co., Ltd. | Amphur Bang Pakong Chachoengsao, Thailand | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vitrolife A/S | Viby J Midtjylland, Denmark | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wuhan Huchuang Union Technology Co., Ltd. | Wuhan Hubei, China | Exporter to the US, 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.