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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

CountryMakers
China9
United States8
India3
United Kingdom2
Switzerland2
Canada2
Brazil1
Slovenia1
Belgium1
Sweden1
Denmark1
Germany1
Italy1
Turkey1
Netherlands1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Albert Browne Ltd.Leicester, United KingdomManufacturer0000api.fda.gov
Aopu Lighting (jinyun) Co., Ltd.Lishui Zhejiang, ChinaManufacturer0000api.fda.gov
Baumer S.A.MOGI MIRIM - SP Sao Paulo, BrazilManufacturer0000api.fda.gov
Belimed AGZug, SwitzerlandComplaint file establishment, Specification developer0000api.fda.gov
Belimed D.O.O.Grosuplje, SloveniaContract manufacturer0000api.fda.gov
Bellus Medical, LLCJohnson City, TN, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Bluewave Technologies, Inc.Orange City, FL, United StatesManufacturer0000api.fda.gov
Dent4you AGHeerbrugg Sankt Gallen, SwitzerlandSpecification developer0000api.fda.gov
Dongguan I-Believe Electronic Appliance Co., Ltd.DongGuan Guangdong, ChinaManufacturer0000api.fda.gov
Dongguan Yingfeng Metal & Plastic Products Co., LtdDongguan Guangdong, ChinaManufacturer0000api.fda.gov
Ear Technology CorporationJohnson City, TN, United StatesSpecification developer0000api.fda.gov
EledricityMerelbeke-Melle Oost-Vlaanderen, BelgiumManufacturer0000api.fda.gov
Endonest Medical Systems LLPPALGHAR Maharashtra, IndiaManufacturer0000api.fda.gov
Getinge Disinfection ABVAXJO Kronoberg, SwedenManufacturer0060api.fda.gov
Guangdong Eraclean Technology Co.,ltdZhongshan City Guangdong, ChinaManufacturer0000api.fda.gov
Heuer International (A division of GST Corporation Limited)NOIDA Uttar Pradesh, IndiaForeign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
KEN Hygiene Systems A/SBroby Syddanmark, DenmarkManufacturer0000api.fda.gov
Mada Medical Products, Inc.Carlstadt, NJ, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Mark EnterprisesNashik Maharashtra, IndiaManufacturer0000api.fda.gov
Medisafe Uk Ltd.Bishops Stortford Hertfordshire, United KingdomComplaint file establishment, Manufacturer0000api.fda.gov
Miele & Cie. KGBielefeld North Rhine-Westphalia, GermanyManufacturer0000api.fda.gov
Medease Life Co.,LtdDANYANG Jiangsu, ChinaContract manufacturer0000api.fda.gov
Miller Technical ServicesPlymouth, MI, United StatesContract manufacturer0000api.fda.gov
Rehabilitation Equipment Associates, IncManchester, NH, United StatesManufacturer0000api.fda.gov
Restec Solutions, LLCChapel Hill, NC, United StatesManufacturer0000api.fda.gov
Scican Ltd.TORONTO Ontario, CanadaContract manufacturer, Manufacturer0000api.fda.gov
Shenzhen Denco Medical Co., Ltd.Shenzhen Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Shenzhen Rogin Medical Co., Ltdshenzhen Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Steelco S.P.A.Riese Pio X Treviso, ItalyComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
STERIS Canada ULCQuebec, CanadaComplaint file establishment, Manufacturer0000api.fda.gov
Sumer Uluslararasi San. Ve Tic. A.S.Sincan Ankara, TurkeyManufacturer0000api.fda.gov
Skytron, LLCGrand Rapids, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Uv Smart Technologies B.V.Rijswijk Zuid-Holland, NetherlandsSpecification developer0000api.fda.gov
Xiamen Forsound Hearing Technology Co.,ltd.Xiamen Fujian, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Zhongshan Sunclean Co.,ltdZhongshan Guangdong, ChinaManufacturer0000api.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.