Data / Medical devices / Degreaser, Skin, Surgical
Degreaser, Skin, Surgical (KOY): 11 FDA-registered makers in 7 countries
11 establishments in 7 countries are registered with the FDA to make Degreaser, Skin, Surgical (product code KOY, Class 1, 21 CFR 878.4730). 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 6 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
- KOY
- Device class
- 1
- Regulation
- 878.4730
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| China | 4 |
| Mexico | 2 |
| Germany | 1 |
| United States | 1 |
| Taiwan | 1 |
| Israel | 1 |
| Italy | 1 |
Makers of Degreaser, Skin, Surgical
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 |
|---|---|---|---|---|---|---|---|---|
| Biviax GMBH & Co KG | Dortmund North Rhine-Westphalia, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Goodwood Medical Care Ltd | Dalian Liaoning, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jinhua Jingdi Medical Supplies Co.,ltd | Jinhua Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Miller Stephenson Medical LLC | Danbury, CT, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Openpatch Inc. | Taipei, Taiwan | Complaint file establishment, Contract manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sion Biotext Medical Ltd | Sderot Southern, Israel | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spes Medica S.P.A | Genova Liguria, Italy | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sion Biotext Mexico, S.A.P.I. De C.V. | Civac Mexico, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sion Biotext Mexico, S.A.P.I. de C.V | Jiutepec Morelos, Mexico | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Banghaoning Medical Supplies Co., Ltd | YiWu Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Excellent United Medical Technology Co.,ltd | Jinhua Zhejiang, 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.