Zeronitec Co., Ltd. is a specialized medical device company developing, manufacturing, and selling low-temperature plasma sterilizers and related accessories. The company's philosophy centers on customer satisfaction and talent management, aiming to establish a safe medical environment through superior technology and quality. It strives to enhance the professionalism of all employees through a people-oriented talent management approach.ZeronitecCo.,Ltd.isaspecializedmedicaldevicecompanydeveloping,manufacturing,andsellinglow-temperatureplasmasterilizersandrelatedaccessories.Thecompany'sphilosophycentersoncustomersatisfactionandtalentmanagement,aimingtoestablishasafemedicalenvironmentthroughsuperiortechnologyandquality.Itstrivestoenhancetheprofessionalismofallemployeesthroughapeople-orientedtalentmanagementapproach.
Key Products/TechnologiesKeyProducts/Technologies
PURE Series Low-Temperature Plasma Sterilizers: A flagship product line comprising PURE 20, PURE 40, PURE 50, and PURE 120(D) models. These sterilizers utilize hydrogen peroxide (H2O2) gas and plasma technology for effective sterilization of medical devices. PURE 40 and PURE 50 models feature a 7-inch wide color touch monitor, while PURE 120 and PURE 120D models are equipped with a 10-inch wide color touch monitor for user-friendly interaction. The PURE 120 model is a large-capacity sterilizer suitable for medium to large general hospitals with high surgical turnover, requiring 5 to 10 or more sterilization cycles daily. The PURE 20 model is an entry-level sterilizer designed for small to medium-sized hospitals and laboratories needing rapid, low-temperature sterilization of small-volume medical items.PURESeriesLow-TemperaturePlasmaSterilizers:AflagshipproductlinecomprisingPURE20,PURE40,PURE50,andPURE120(D)models.Thesesterilizersutilizehydrogenperoxide(H2O2)gasandplasmatechnologyforeffectivesterilizationofmedicaldevices.PURE40andPURE50modelsfeaturea7-inchwidecolortouchmonitor,whilePURE120andPURE120Dmodelsareequippedwitha10-inchwidecolortouchmonitorforuser-friendlyinteraction.ThePURE120modelisalarge-capacitysterilizersuitableformediumtolargegeneralhospitalswithhighsurgicalturnover,requiring5to10ormoresterilizationcyclesdaily.ThePURE20modelisanentry-levelsterilizerdesignedforsmalltomedium-sizedhospitalsandlaboratoriesneedingrapid,low-temperaturesterilizationofsmall-volumemedicalitems.
Sterilant Cassettes and Accessories: The sterilant cassettes used with PURE 40 and PURE 50 models incorporate patented technology for multiple-cycle use (7 cycles/cassette). These cassettes feature a constant H2O2 dose system and a barcode system for tracking information, with 100% sealed capsules to prevent leakage during storage and transportation. The company also provides various accessories, including biological indicators (SCBI) and chemical indicators (CI Tape & CI Strip), to enhance the reliability of the sterilization process.SterilantCassettesandAccessories:ThesterilantcassettesusedwithPURE40andPURE50modelsincorporatepatentedtechnologyformultiple-cycleuse(7cycles/cassette).ThesecassettesfeatureaconstantH2O2dosesystemandabarcodesystemfortrackinginformation,with100%sealedcapsulestopreventleakageduringstorageandtransportation.Thecompanyalsoprovidesvariousaccessories,includingbiologicalindicators(SCBI)andchemicalindicators(CITape&CIStrip),toenhancethereliabilityofthesterilizationprocess.
Advanced Plasma Technology and Control Systems: High-voltage plasma technology offers efficient sterilization performance with low replacement costs. The principle involves the generation of hydroxyl radicals (OH-) and other radicals from H2O2 gas exposed to plasma, which effectively kills all microorganisms. Furthermore, the sterilizers are equipped with an embedded computer system, cycle parameter graphs, cassette graphs, a patented LED display for process monitoring, USB and LAN ports, and a user login system for advanced control and monitoring capabilities.AdvancedPlasmaTechnologyandControlSystems:High-voltageplasmatechnologyoffersefficientsterilizationperformancewithlowreplacementcosts.Theprincipleinvolvesthegenerationofhydroxylradicals(OH-)andotherradicalsfromH2O2gasexposedtoplasma,whicheffectivelykillsallmicroorganisms.Furthermore,thesterilizersareequippedwithanembeddedcomputersystem,cycleparametergraphs,cassettegraphs,apatentedLEDdisplayforprocessmonitoring,USBandLANports,andauserloginsystemforadvancedcontrolandmonitoringcapabilities.
Core AdvantagesCoreAdvantages
Innovative Low-Temperature Plasma Sterilization Technology: The utilization of hydrogen peroxide gas and plasma technology enables safe sterilization of heat-sensitive medical devices. This technology is applicable to a wide range of medical instruments, including fiber optic endoscopes, surgical telescopes, ophthalmic instruments, and catheters. A key benefit is its eco-friendliness, as H2O2 decomposes into H2O and O2 after sterilization, leaving no harmful residues to humans or the environment.InnovativeLow-TemperaturePlasmaSterilizationTechnology:Theutilizationofhydrogenperoxidegasandplasmatechnologyenablessafesterilizationofheat-sensitivemedicaldevices.Thistechnologyisapplicabletoawiderangeofmedicalinstruments,includingfiberopticendoscopes,surgicaltelescopes,ophthalmicinstruments,andcatheters.Akeybenefitisitseco-friendliness,asH2O2decomposesintoH2OandO2aftersterilization,leavingnoharmfulresiduestohumansortheenvironment.
User Convenience and Safety: The multi-cycle cassette-type sterilant ensures leak prevention and safe transport/storage, complemented by a barcode system for information tracking. The PURE 120 model's automatic sliding door, operable by a foot switch, provides hands-free operation, enhancing user convenience and safety. Additionally, color-coded LED displays and touchscreen interfaces facilitate easy monitoring and operation of the sterilization process.UserConvenienceandSafety:Themulti-cyclecassette-typesterilantensuresleakpreventionandsafetransport/storage,complementedbyabarcodesystemforinformationtracking.ThePURE120model'sautomaticslidingdoor,operablebyafootswitch,provideshands-freeoperation,enhancinguserconvenienceandsafety.Additionally,color-codedLEDdisplaysandtouchscreeninterfacesfacilitateeasymonitoringandoperationofthesterilizationprocess.
Global Market Competitiveness and Certifications: Over a decade of accumulated technology and expertise in the medical industry has enabled the company to penetrate more than 30 overseas markets. It holds numerous domestic and international certifications, including CE, ISO 13485, EN ISO 13485 (Medical Device Quality Management System), KGMP, KFDA, and Venture Company certification. The acquisition of the European CE certification, in particular, validates the product's quality and safety on a global scale.GlobalMarketCompetitivenessandCertifications:Overadecadeofaccumulatedtechnologyandexpertiseinthemedicalindustryhasenabledthecompanytopenetratemorethan30overseasmarkets.Itholdsnumerousdomesticandinternationalcertifications,includingCE,ISO13485,ENISO13485(MedicalDeviceQualityManagementSystem),KGMP,KFDA,andVentureCompanycertification.TheacquisitionoftheEuropeanCEcertification,inparticular,validatestheproduct'squalityandsafetyonaglobalscale.
Continuous R&D and Customer-Centric Management: The company is dedicated to ongoing research and development for human health, consistently launching new medical devices related to infection control. Its management philosophy prioritizes customer satisfaction, building trust through superior technology and quality. Through talent management focused on enhancing employee expertise, the company continuously invests in its goal of becoming a global enterprise.ContinuousR&DandCustomer-CentricManagement:Thecompanyisdedicatedtoongoingresearchanddevelopmentforhumanhealth,consistentlylaunchingnewmedicaldevicesrelatedtoinfectioncontrol.Itsmanagementphilosophyprioritizescustomersatisfaction,buildingtrustthroughsuperiortechnologyandquality.Throughtalentmanagementfocusedonenhancingemployeeexpertise,thecompanycontinuouslyinvestsinitsgoalofbecomingaglobalenterprise.
Target IndustrieTargetIndustrie
Healthcare Facilities: General hospitals, small and medium-sized hospitals, operating theaters (OT), central sterile services departments (CSSD), dental clinics, ophthalmology clinics, orthopedic departments, and endoscopy centers.HealthcareFacilities:Generalhospitals,smallandmedium-sizedhospitals,operatingtheaters(OT),centralsterileservicesdepartments(CSSD),dentalclinics,ophthalmologyclinics,orthopedicdepartments,andendoscopycenters.
Research and Laboratories: Biological laboratories (Biolabs) and other research facilities.ResearchandLaboratories:Biologicallaboratories(Biolabs)andotherresearchfacilities.
Veterinary Hospitals: Veterinary clinics for animal treatment.VeterinaryHospitals:Veterinaryclinicsforanimaltreatment.
Medical Device Manufacturers: Sterilization processes during medical device production.MedicalDeviceManufacturers:Sterilizationprocessesduringmedicaldeviceproduction.
Major MarketsMajorMarkets
Philippines, Kazakhstan, Vietnam, Indonesia, Malaysia, Uzbekistan, India, Saudi ArabiaPhilippines,Kazakhstan,Vietnam,Indonesia,Malaysia,Uzbekistan,India,SaudiArabia
Brazil, ColombiaBrazil,Colombia
Certifications/PatentsCertifications/Patents
CE Certification: Essential certification for export to European markets.CECertification:EssentialcertificationforexporttoEuropeanmarkets.
ISO 13485, EN ISO 13485: Medical Device Quality Management System certification.ISO13485,ENISO13485:MedicalDeviceQualityManagementSystemcertification.
ISO 9001:2008: Quality Management System certification.ISO9001:2008:QualityManagementSystemcertification.
KGMP (Korea Good Manufacturing Practice): Certification of conformity to medical device manufacturing and quality control standards.KGMP(KoreaGoodManufacturingPractice):Certificationofconformitytomedicaldevicemanufacturingandqualitycontrolstandards.
KFDA (Korea Food & Drug Administration): Manufacturing/item approval from the Ministry of Food and Drug Safety.KFDA(KoreaFood&DrugAdministration):Manufacturing/itemapprovalfromtheMinistryofFoodandDrugSafety.
Venture Company Certification: Recognized as a venture company by the Korea Technology Finance Corporation (KIBO).VentureCompanyCertification:RecognizedasaventurecompanybytheKoreaTechnologyFinanceCorporation(KIBO).
Patent Registrations: Two patents related to plasma sterilization systems (2013), two patents related to hydrogen peroxide plasma sterilizers (2017), and patented technology for sterilant cassettes and LED displays.PatentRegistrations:Twopatentsrelatedtoplasmasterilizationsystems(2013),twopatentsrelatedtohydrogenperoxideplasmasterilizers(2017),andpatentedtechnologyforsterilantcassettesandLEDdisplays.
International Patents: Brazil Patent PCT (BR11 2019 022113-1), International Patent Application PCT (PCT/KR2017/005806).InternationalPatents:BrazilPatentPCT(BR112019022113-1),InternationalPatentApplicationPCT(PCT/KR2017/005806).
International Regulatory Approvals: Saudi SFDA (2021), Brazil ANVISA (2019), Kazakhstan KGHOST (2019) acquisition.InternationalRegulatoryApprovals:SaudiSFDA(2021),BrazilANVISA(2019),KazakhstanKGHOST(2019)acquisition.