Clinically Evaluated Manufacturers, Suppliers & Companies
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Manufacturerbased in Roseville, MINNESOTA (USA)
Rebiotix Inc., a Ferring Company, is a clinical stage biotechnology company founded to revolutionize the treatment of debilitating diseases by harnessing the power of the human microbiome. The company is on the forefront of an exciting potential ...
Rebiotix - Model RBX7455 - Microbiota Based Product for Clinical Evaluation
Rebiotix Inc., a Ferring Company, has leveraged its clinical, manufacturing and regulatory experience with RBX2660 to develop the first of its kind non-frozen, room temperature stable oral microbiota-based formulation under the ...
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Service providerbased in Moonachie, NEW YORK (USA)
Sterling Medical Devices, a fully staffed U.S. based medical device engineering firm, is entirely dedicated to helping our clients resolve medical device design and development challenges“ from concept through completion “ by applying our expertise ...
Clinical Evaluation Reports
All medical devices sold in the EU must have a Clinical Evaluation Report (CER) as part of its technical documentation to satisfy the new EU Medical Device Regulation (MDR) requirements. A comprehensive analysis of ...
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Manufacturerbased in Chengdu, CHINA
Maccura Biotechnology Co., Ltd. is a professional enterprise to research and manufacture clinical IVD products. Maccura was founded in 1994 and has been focusing on the research, manufacture, marketing, and services of IVD products. Maccura is a ...
Maccura - Model SARS-CoV-2 IgM(CLIA) / SARS-CoV-2 IgG(CLIA) - Automatic Chemiluminescence Analyzer
Compatible with i 3000 and i 1000 automatic chemiluminescence analyzer. SARS-CoV-2 IgM, IgG separate detection. Apply to serum and plasma. Pretreatment is not required. Response time is 20 minutes. Open vial expiry date is up to 35 ...
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Manufacturerbased in Pearl River, NEW YORK (USA)
Auro Vaccines LLC is a clinical-stage vaccine development company pioneering a major evolutionary step in the design and development of preventive and therapeutic vaccines for infectious diseases. Our novel approach is based on a proprietary ...
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Manufacturerbased in Cardiff, UNITED KINGDOM
Alesi Surgical was founded in 2009 to develop and commercialise products that improve the safety, efficacy and outcomes of surgical procedures. The company is a spin-out from the Welsh Institute for Minimal Access Therapy (WIMAT), a leading surgical ...
Alesi Surgical - Collaboration with WIMAT
Alesi Surgical and WIMAT are co-located and collaborate on research and development, testing, product design, pre-clinical evaluation and post-market clinical follow-up. This provides a unique level ...
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Technologybased in Yongin-si, SOUTH KOREA
Vivozon is a global innovative drug development company established in 2008. We built an efficacy-based new drug discovery system that is clearly distinct from the existing new drug development paradigm, and discovered the non- narcotic analgesic ...
Vivozon - Model PT-VVZ149-02 - Pharmacokinetics of VVZ-149 Injection
Single-dose, escalation clinical trial to evaluate the safety and pharmacokinetics of VVZ-149 injection in healthy elderly ...
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Manufacturerbased in Kunshan, Suzhou, CHINA
PeakSonic is a global medical equipment company specialised in the field of urology. We are committed to providing products and services with excellent quality, as well as the application of ultrasound technology in this field. The main products of ...
PeakSonic - Model M1 - Handheld Portable Bladder Volume Instrument
PeakSonic M1 is a handheld portable bladder volume instrument, which can be applied in the department of Surgery, Emergency, ICU, Obstetric, Gynecology, radiotherapy and nursing home. It can provide the basis for clinical ...
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Manufacturerbased in Rudniki k/Czestochowy, POLAND
The Factory of Medical Instruments CHIRMED is located in Rudniki, near Czestochowa. It is a manufacturer of surgical and dental instruments and non-medical components made of stainless steel and titanium. From the beginning of its existence, that is ...
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Manufacturerbased in Anyang-si, SOUTH KOREA
Alpinion is located at the pinnacle of the medical industry and is determined to be one of the pillars of a life-long partner for customers, society, and humanity. Each member of ALPINION strives for innovation as an expert and a pioneer in their ...
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Manufacturerbased in Escondido, CALIFORNIA (USA)
An objective and quantitative point-of-care diagnostic test that provides precise and predictive information. The TearLab Osmolarity System* is intended to measure the osmolarity of human tears to aid in the diagnosis of dry eye disease in patients ...
TearLab - Osmolarity System
of having dry eye disease, in conjunction with other methods of clinical ...
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Service providerbased in Whitley Bay, UNITED KINGDOM
Let EDSL plan & support your regulatory and quality pathway. With over 22 years'? of experience guiding clients along the winding regulatory pathway of ever changing regulations and standards, let EDSL steer you to a successful outcome, using the ...
EU MDR Transition Services
the new requirements. The MDR introduces greater scrutiny of technical documentation, clinical evaluations, post-market clinical follow-ups (PMCF) and demands end-to-end traceability of medical ...
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Manufacturerbased in Leeds, UNITED KINGDOM
Founded in 2009, Leeds-based Arterius is developing a next-generation bioresorbable cardiovascular scaffold (stent) with an emerging market-leading clinical profile. The founding directors have significant experience in the development of medical ...
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Manufacturerbased in New Haven, CONNECTICUT (USA)
BioXcel Therapeutics, Inc. is a clinical-stage biopharmaceutical company utilizing artificial intelligence, or AI, approaches to develop transformative medicines in neuroscience and immuno-oncology. We are focused on utilizing cutting-edge ...
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Manufacturerbased in Rainbach, AUSTRIA
Genspeed Biotech was founded in fall 2016 as a spin-off company of Greiner Bio-One. Highly qualified employees are devoted to the development, production and sales of in-vitro diagnostic. Basis is the patented Genspeed technology that was further ...
Genspeed Biotech - Model FSME IgG xPOC - Antibody Detection via µELISA
The FSME IgG xPOC test is an antibody test which provides results in laboratory quality from one drop of blood on-site within 20 minutes. The test detects specific IgG antibodies after vaccination against tick-borne encephalitis (TBE) in laboratory ...
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Manufacturerbased in Brighton, UNITED KINGDOM
Destiny Pharma is a clinical phase biotechnology company dedicated to the development of novel anti-infectives with a focus on infection prevention. We have two exciting late-stage clinical assets and a range of earlier research programmes. Our ...
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Manufacturerbased in New York, NEW YORK (USA)
SIGA Technologies, Inc. is a public, commercial-stage pharmaceutical company focused on providing solutions for unmet needs in the health security market that comprises medical countermeasures against chemical, biological, radiological, and nuclear ...
Liquid Suspension Pediatric Formulation
and support from BARDA. Formulation prototypes have been generated and will undergo clinical evaluation. ...
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Manufacturerbased in Marlborough, MASSACHUSETTS (USA)
Cognoptix is developing a simple, innovative, non-invasive beta amyloid eye scanning test for use in adult patients being evaluated for Alzheimer’s Disease to aid in early diagnosis of this complex and devastating ...
Cognoptix - SAPPHIRE II System
Cognoptix’ SAPPHIRE platform is a compact, easy to use, clinical device for in situ patient examination in the comfort of a doctor’s office. The combined platform is currently available in the United ...
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Manufacturerbased in Stockholm, SWEDEN
NoseOption AB is a MedTech company manufacturing and selling nasal breathing devices. With a vision to create a better breathing experience for everyone, NoseOption offers a unique portfolio of nasal devices that filters out odor, allergens, smog, ...
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Manufacturerbased in Dundee, UNITED KINGDOM
Our expertise encompasses the development of novel proprietary diagnostic tests in areas of clinical need and their incorporation onto the menus of the high throughput analysers of our partners, using a variety of assay technologies. Our proprietary ...
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Manufacturerbased in Nanjing, CHINA
Founded in 2002, Jiji Biotech Co., Ltd.is a medical and health industry chain that integrates independent research and development, large-scale production and professional marketing. It has many subsidiaries and offices at home and abroad. the ...
Getein Biomedical - CK-MB Fast Test Kit (Immunofluorescence Assay)
Getein CK-MB Fast Test Kit is used as an aid in the clinical diagnosis, prognosis and evaluation of myocardial injury such as Acute Myocardial Infarction (AMI), Unstable Angina, Acute Myocarditis and Acute Coronary ...
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