Data / Medical devices / Processor, Tissue, Automated
Processor, Tissue, Automated (IEO): 27 FDA-registered makers in 11 countries
27 establishments in 11 countries are registered with the FDA to make Processor, Tissue, Automated (product code IEO, Class 1, 21 CFR 864.3875). 0 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 12 510(k) clearances under this code, the latest on December 29, 1992, and lists 11 recall events (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- IEO
- Device class
- 1
- Regulation
- 864.3875
- Medical specialty
- Pathology
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| China | 5 |
| India | 5 |
| Germany | 3 |
| Italy | 2 |
| Malaysia | 1 |
| South Korea | 1 |
| Spain | 1 |
| Australia | 1 |
| Japan | 1 |
| United Kingdom | 1 |
Makers of Processor, Tissue, Automated
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 |
|---|---|---|---|---|---|---|---|---|
| Ave Science & Technology Co., Ltd | Changsha Hunan, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biocytech Corporation Sdn Bhd | Perak, Malaysia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biogenex Laboratories Inc. | Fremont, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cellsolutions LLC | Greensboro, NC, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Core Biotech Co., Ltd. | Gwangju, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dakewe(shenzhen) Medical Equipment Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diapath S.P.A. | Martinengo Bergamo, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Especialidades Medicas Myr SL | Llorenc del Pendes Tarragona, Spain | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Four E's Scientific Co., Ltd. | GUANGZHOU Guangdong, China | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Healthsky Biotechnology Co., Ltd. | Hangzhou City Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Leica Biosystems Melbourne Pty Ltd | MELBOURNE Victoria, Australia | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Leica Biosystems Nussloch GMBH | NUSSLOCH Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 2 | 0 | api.fda.gov | |
| Leica Instruments (Shanghai) Co., Ltd. | Shanghai, China | Contract manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mark Enterprises | Nashik Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medimeas Instruments | Ambala Cantt Haryana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medite Medical GMBH | Burgdorf Lower Saxony, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Milestone S.P.A. | Sorisole Bergamo, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pathnsitu Biotechnologies Pvt Ltd | HYDERABAD Telangana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rushabh Instruments, LLC | Ivyland, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sakura Seiki Co., Ltd. | CHIKUMA-CITY Nagano, Japan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scientific Supplies & Technology, Inc. | Doral, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shandon Diagnostics Limited | RUNCORN Cheshire East, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sipcon Technologies Private Limited | Ambala Haryana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Slee Medical GMBH | Nieder-Olm Rhineland-Palatinate, Germany | Complaint file establishment, Exporter to the US, Foreign private label distributor, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ted Pella, Inc. | Redding, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Uni Meditrek Private Limited | Ghaziabad Uttar Pradesh, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 29, 1992. 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.