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Iso 13485 Equipment Supplied In Usa
144 equipment items found
Manufactured by:AHA Hyperbarics GmbH based inVienna, AUSTRIA
Working pressure of the chamber: 200 kPa (2.0 bar, 2.0 ATA or 15 psi). Manufactured: in accordance with EN ISO 13485:2016 quality management system ...
by:Qualityze Inc based inTampa, FLORIDA (USA)
Safety and quality are non-negotiable in the medical devices industry, that’s why we developed ISO 13485. Regulatory requirements are increasingly stringent throughout every step of a product’s life cycle, including service and delivery. Increasingly, organizations in the industry are expected to demonstrate their quality management processes and ...
Manufactured by:Polysciences, Inc. based inWarrington, PENNSYLVANIA (USA)
MAXgene GMP capitalizes on the efficiency and scalability of Polysciences’ PEI MAX while adding the validation process and regulatory components necessary for moving into clinical and commercial manufacturing. It is manufactured in accordance with cGMP under an ISO 13485 Quality Management ...
Manufactured by:Diatron based inBudapest, HUNGARY
Diatron hematology systems are comprised of analyzers and barcoded reagents, controls and calibrators. The systems were designed to ensure the highest performance and confidence in results. Diatron is ISO 13485 and ISO 9001 certified which ensures consistent product quality, supply and performance. ...
Manufactured by:Integrated DNA Technologies, Inc. based inCoralville, IOWA (USA)
IDT provides primers and probes for these CDC assays for the identification of virus. The primers and probes are manufactured at IDT under ISO 13485:2016 conditions and are available for research use only (RUO). The kits include primers and 5’ FAM / ZEN™ / 3’ Iowa Black™ FQ probes. 2019-nCoV controls* are available ...
Manufactured by:Luxfer MEL Technologies based inManchester, UNITED KINGDOM
Our development and manufacture is the ISO 13485 quality system, this is a requirement for future medical device regulations. Our dedicated facility offers high quality material and process control, this lowers customers risk. We can support programmes from kg to tonne; scalability and capability to support programmes through to success. ...
Manufactured by:TPC Mechatronics based inSeo-gu, SOUTH KOREA
ISO 13485 (Medical Devices: Quality Management Systems), 1 Light source, 1 Detection (No Crosstalk). 4 Channel Multiplex(Covid19 + General Flu Simultaneous Testing). Advanced modular optic module. ...
Manufactured by:RS Medical based inVancouver, WASHINGTON (USA)
RS Medical electrodes are manufactured in the USA in accordance with ISO 13485 and CE certified manufacturing practices to ensure the highest possible levels of process and quality control. All RS Medical electrode products are also latex free to accommodate those with latex sensitivities. ...
Manufactured by:AHA Hyperbarics GmbH based inVienna, AUSTRIA
Working pressure of the chamber: 200 kPa (2.0 bar, 2.0 ATA or 15 psi). Certificate: Class IIb Medical Device (MDD 93/42/EEC). Manufactured in accordance with EN ISO 13485:2016 quality management system standard. Designed according to EN 14931:2006 ...
Manufactured by:Bio Molecular Systems based inUpper Coomera, AUSTRALIA
The world’s first magnetic induction cycler is now a registered medical device with CE-IVD and TGA approval. Mic IVD is manufactured under an ISO 13485:2016 Quality Management System. ...
Manufactured by:TPC Mechatronics based inSeo-gu, SOUTH KOREA
ISO 13485(Medical device quality control) certification. Standard Deep Well Plate(Open Platform) application. Reasonable Price(70% compared to competitors), High performance. ...
Manufactured by:Nordson Medical based inHuntington Beach, CALIFORNIA (USA)
We know that speed to market is key, so we offer expertise in premium, medical-grade extruded tubing with expanded capacity in our U.S. and European facilities with less than two weeks lead time on new projects specific to multi-layer PTA/PTCA applications, single-lumen, and multi-lumen tubing. We also scale to your production needs with confidence through FDA registered production sites, ...
Manufactured by:Integrated DNA Technologies, Inc. based inCoralville, IOWA (USA)
We have combined our proven oligo manufacturing expertise and ISO 13485 certified production processes to deliver GMP-manufactured MGB Eclipse Probes and companion primers. Together, these probe and primer pairs are ideal for genotyping qPCR assays. Our range of fluorophore options (FAM, HEX, TET, and Yakima Yellow® (EliTech Group)) allows you to ensure ...
Manufactured by:Spire Integrated Solutions based inOrlando, FLORIDA (USA)
PRIMUS sterilizers are designed and manufactured in the USA according to Quality Management Systems which are in compliance with ISO 9001:2008, ISO 13485:2003, CMDCAS and FDA's Good Manufacturing Practice (GMP) for Medical Devices: General regulation (21CFR Part 820). Medium size sterilizers are one segment of 12 standard clinical sizes ...
Manufactured by:SS Innovations International Inc. based inFort Lauderdale, FLORIDA (USA)
Furthermore, the platform offers advanced pre-operative guidance applications to enhance surgical planning tasks. Its features are supported by EN ISO 13485:2016 certification and it holds the CDSCO Manufacturing License, ensuring adherence to high manufacturing and operational ...
Manufactured by:Exceleron Medical, Inc. based inSaint Paul, MINNESOTA (USA)
Medical injection molding - Exceleron Medical offers injection molding services to medical device companies. Exceleron Medical is ISO 13485:2016 certified as a filtration manufacturer and our molding machines operate under the same ISO quality system in order to provide each customer with exceptional quality control from batch to batch, while ...
Manufactured by:EnColl Corporation based inFremont, CALIFORNIA (USA)
The collagen used in the Hemocoll product is based on a patented technology that ensures the high purity of Type-I collagen. It is processed under ISO 13485 conditions and with stringent USP quality tests as per WHO (World Health Organization) and other international ...
Manufactured by:Tissue Genesis based inNew Albany, INDIANA (USA)
In the USA, FDA-approved clinical IDE studies using the Icellator and Cell Icellation Kit are underway for multiple indications. Produced under ISO 13485 according to 21 CFR 820 ...
Manufactured by:Keller Technology Corporation (KTC) based inTonawanda, NEW YORK (USA)
Keller Technology Corporation (KTC) specializes in the manufacture of complex electromechanical equipment, and we have experience manufacturing automated systems for health care OEMs across the globe. We follow Current Good Manufacturing Practices (cGMP), and our facilities are ISO 9001 and ISO 13485 certified, so we have the qualifications and ...
Manufactured by:HOBBS MEDICAL INC. based inSTAFFORD SPRINGS, CONNECTICUT (USA)
Push Catheters support therapeutic ERCP for the precise placement of biliary and pancreatic stents. These products are developed and manufactured in the USA, adhering to the ISO 13485 standards, ensuring their quality and compliance for medical use ...