Data / Medical devices / Disinfector, Medical Devices
Disinfector, Medical Devices (MEC): 35 FDA-registered makers in 15 countries
35 establishments in 15 countries are registered with the FDA to make Disinfector, Medical Devices (product code MEC, Class 2, 21 CFR 880.6992). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on June 20, 2008, and lists 24 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MEC
- Device class
- 2
- Regulation
- 880.6992
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| China | 9 |
| United States | 8 |
| India | 3 |
| United Kingdom | 2 |
| Switzerland | 2 |
| Canada | 2 |
| Brazil | 1 |
| Slovenia | 1 |
| Belgium | 1 |
| Sweden | 1 |
| Denmark | 1 |
| Germany | 1 |
| Italy | 1 |
| Turkey | 1 |
| Netherlands | 1 |
Makers of Disinfector, Medical Devices
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 |
|---|---|---|---|---|---|---|---|---|
| Albert Browne Ltd. | Leicester, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aopu Lighting (jinyun) Co., Ltd. | Lishui Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Baumer S.A. | MOGI MIRIM - SP Sao Paulo, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Belimed AG | Zug, Switzerland | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Belimed D.O.O. | Grosuplje, Slovenia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bellus Medical, LLC | Johnson City, TN, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bluewave Technologies, Inc. | Orange City, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dent4you AG | Heerbrugg Sankt Gallen, Switzerland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan I-Believe Electronic Appliance Co., Ltd. | DongGuan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Yingfeng Metal & Plastic Products Co., Ltd | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ear Technology Corporation | Johnson City, TN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eledricity | Merelbeke-Melle Oost-Vlaanderen, Belgium | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Endonest Medical Systems LLP | PALGHAR Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Getinge Disinfection AB | VAXJO Kronoberg, Sweden | Manufacturer | 0 | 0 | 6 | 0 | api.fda.gov | |
| Guangdong Eraclean Technology Co.,ltd | Zhongshan City Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heuer International (A division of GST Corporation Limited) | NOIDA Uttar Pradesh, India | Foreign private label distributor, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| KEN Hygiene Systems A/S | Broby Syddanmark, Denmark | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mada Medical Products, Inc. | Carlstadt, NJ, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mark Enterprises | Nashik Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medisafe Uk Ltd. | Bishops Stortford Hertfordshire, United Kingdom | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Miele & Cie. KG | Bielefeld North Rhine-Westphalia, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medease Life Co.,Ltd | DANYANG Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Miller Technical Services | Plymouth, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rehabilitation Equipment Associates, Inc | Manchester, NH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Restec Solutions, LLC | Chapel Hill, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scican Ltd. | TORONTO Ontario, Canada | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Denco Medical Co., Ltd. | Shenzhen Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Rogin Medical Co., Ltd | shenzhen Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Steelco S.P.A. | Riese Pio X Treviso, Italy | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STERIS Canada ULC | Quebec, Canada | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sumer Uluslararasi San. Ve Tic. A.S. | Sincan Ankara, Turkey | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Skytron, LLC | Grand Rapids, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Uv Smart Technologies B.V. | Rijswijk Zuid-Holland, Netherlands | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Forsound Hearing Technology Co.,ltd. | Xiamen Fujian, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhongshan Sunclean Co.,ltd | Zhongshan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 20, 2008. 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.