Medical tests - Import export

Our company has been growing for 20 years with the goal of One Health. - Mission: Contribute to human and animal health with diagnostic business. - Vision: Company supplying the world’s highest quality diagnostic kits.

Syringe Testing is a critical step in developing and commercializing needlebased injection systems for medical use. By testing mechanical properties, such as breakloose and glide force, as well as biocompatibility, extractables and leachables, sterility, packaging and transit properties, we can determine if the device is within standard specifications, reducing the likelihood of improper function. Eurofins Medical Device Testing network of laboratories has experience performing an array of standard and nonstandard testing on syringes to verify their safety. Choose Eurofins Medical Device Testing to help you Determine the necessary testing requirements for your device Write GMPcompliant and ISO standard driven protocols and methods Perform the required tests to demonstrate that the expected performance criteria are satisfied Complete batch release activities and/or gain regulatory approval

Medical device testing is tightly regulated due to the potential severity of an EMC or Safety failure. The term 'medical device' covers a wide range of items and we have extensive experience in testing in this area, covering items such as prosthetic limbs, hospital beds, patient monitors, TENS machines, blood pressure monitors, to name just a few. We are UKAS accredited to test for the Medical standards IEC/EN 60601-1 and IEC/EN 60601-1-2, covering the basic safety and essential performance of medical electrical equipment. We are also UKAS accredited for the following specific medical standards: -IEC 60601-1-11 Particular requirements for medical electrical equipment and medical electrical systems in the home healthcare environment -IEC 60601-2-10 Particular requirements for the safety of nerve and muscle stimulators Using a UKAS accredited laboratory gives manufacturers assurance accuracy, reliability and consistency.

Dianel®-Micro Microscopy Analysis Software for Health Hiagnostic with digital dark-field microscope or bright- field microscope supports the following Blood analysis methods: LBA (Live Blood Analysis, Hemaview) Dark-field blood microscopy according to Enderlein Blood analysis by Bradford system called HLB Dry blood analysis Oxidative stress levels and vitamin deficiencies (by Lagard and Heitan) Inflammations observable under the microscope Pleomorphism study by Bechamp microzymas Blood and tissues analysis by Dr. Prof. Gunther Enderlein concept of the pleomorphism of microorganisms Blood and tissues analysis by Dr. Prof. Gunther Enderlein hypotheses about the origins of cancer Classic medical Clinical Complete Blood Count research Research on diseases of saliva Assessment of the condition of the skin, nails and hair in cosmetology Free two-mounts trial available Free support and software updates

COVID-19 Test kit Sejoy 5T has developed the COVID-19 antigen test cassette 3in1 for quick detection. The COVID-19 Antigen Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of Covid-19 antigen in the nasopharynx, oropharynx and nasal swabs, to support the diagnosis of a Covid-19 virus infection. CE certified (CE 1434) Sensitivity: 94,5 % Specificity: 99,9 % Clear result after less than 10 minutes Simple and painless application Fast test result CE certified and therefore approved throughout Europe CE 1434) BfArM listed evaluated by the Paul Ehrlich Institute reacts to the Omikron mutant very high reliability Recognizes a variety of mutations Set consisting of 1 test cassette 1 Sterile swab 1 extraction tube 1 extraction buffer 1 instruction leaflet 1 qualification certificate 1 workstation 1 biowaste bag Packing: 5 pcs.

COVID-19 Test kit Testsealabs has developed the COVID-19 antigen test cassette 3in1 for quick detection. The COVID-19 Antigen Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of Covid-19 antigen in the nasopharynx, oropharynx and nasal swabs, to support the diagnosis of a Covid-19 virus infection. Technical specifications Testsealabs • 1 Box / 25 pack • Professional application (only for professional use) • Rapid test 3 in 1 • Approved in Germany • TÜV Süd EN ISO 13485:2016 • BFarm number: AT082 / 20 • CE certified and reimbursable test listed at the Federal Institute for Drugs and Medical Devices according to the Coronavirus Test Ordinance (TestV) • 97.6% sensitivity • 98.4% specificity • With a separate buffer solution

COVID-19 Test kit Greentspring has developed the COVID-19 antigen test cassette 4 in1 for quick detection. The COVID-19 Antigen Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of Covid-19 antigen in the lolli, nasopharynx, oropharynx and nasal swabs, to support the diagnosis of a Covid-19 virus infection. Technical specifications Greenspring • 1 Box / 25 pack • Professional application (only for professional use) • Rapid test 4 in 1 • Approved in Germany • EN ISO 13485:2016 • BFarm number: AT417/20 • CE certified and reimbursable test listed at the Federal Institute for Drugs and Medical Devices according to the Coronavirus Test Ordinance (TestV) • 96.77% sensitivity • 100% specificity • With a integrated buffer solution

COVID-19 Test kit Sejoy 5T has developed the COVID-19 antigen test cassette 3in1 for quick detection. The COVID-19 Antigen Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of Covid-19 antigen in the nasopharynx, oropharynx and nasal swabs, to support the diagnosis of a Covid-19 virus infection. CE certified (CE 1434) Sensitivity: 94,5 % Specificity: 99,9 % Clear result after less than 10 minutes Simple and painless application Fast test result CE certified and therefore approved throughout Europe CE 1434) BfArM listed evaluated by the Paul Ehrlich Institute reacts to the Omikron mutant very high reliability Recognizes a variety of mutations Set consisting of 1 test cassette 1 Sterile swab 1 extraction tube 1 extraction buffer 1 instruction leaflet 1 qualification certificate 1 workstation 1 biowaste bag Packing: 1 pcs.

COVID-19 Test kit Bioteke has developed the COVID-19 antigen test cassette 3in1 for quick detection. The COVID-19 Antigen Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of Covid-19 antigen in the nasopharynx, oropharynx and nasal swabs, to support the diagnosis of a Covid-19 virus infection. Rapid tests are individually packaged and are therefore ideally intended for quick use. The special features are the easy sampling, easy to read and clearly displayed results and the result is available even after 15-20 minutes. Technical specifications Bioteke Pack • 20 pack Carton • 25 boxes – 500 pieces Standards – and market conformity • Professional application (only for professional use) • Rapid test 3 in 1 • TÜV Süd EN ISO 13485:2016 • BFarm number: AT082 / 20 • CE certified and reimbursable test listed at the Federal Institute for Drugs and Medical Devices according to the Coronavirus Test Ordinance TestV • 97.6% sensitivity • 98.

The Covid-19 Antigen Rapid Test Casserre is a lateral flow immunoassay intended fort he qualitative detection Sars-Cov-2 nucleocapsid antigens in nasophartngeal swab and orosharyngeal wsab from individuals wha are suspected of COVID-19 by their healtcare provider.

Suitable for the qualitative detection of SARS-CoV-2 (COVID-19) N-Protein IgM and IgG antibodies in human serum, whole blood, or finger prick samples. SARS Cov-2 ig G/ig M ANTIBODY TEST KIT turned out to be very specific (none false positive) and to be sensitive enough after 15 days from onset of symptom. These easy to use IgG/IgM combined test kits are the first ones allowing a screening with CWB sample, by typing from a finger prick. These rapid tests are particularly interesting for screening in low resource settings.

AbC-19™ is a COVID-19 (SARS-CoV-2) neutralising antibody lateral flow test and produces results in 20 minutes from a small blood sample. This flexible, easy solution confirms the presence of IgG neutralising antibodies following COVID-19 infection or vaccination: an important factor in interpreting a person’s immunity status. This reliable and accurate (Sensitivity: 98.03%, Specificity: 99.56%) test can be used by trained professionals or trained lay users. The AbC-19™ testing solution is a powerful tool for limiting risks and helping governments, individuals and businesses make more informed decisions about COVID safety and vaccine programmes. An antibody certificate smartphone app is available upon request.

Sugentech SGTi-flex COVID-19 Ag is an immunoassay for qualitative detection of Nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal and nasal swab specimen. • Specimen: Nasopharyngeal (or Nasal) swab • One Step, Fast results within 15 min • Full package for the whole test procedure, No need for additional tool/device - Swab - Buffer - Test Cassette • Package: 1 test kit *all prices are ex vat * shipping is free on orders over 1000 units to one location Product No. CAGT001E0 Description COVID-19 Antigen Lateral Flow Test. For self-testing only. Approvals CE Marked, MHRA registered Intended Use An immunoassay for qualitative detection of Nucleocapsid protein antigen from SARS-CoV-2 in nasal swab specimen. Accuracy Overall Accuracy Sensitivity Specificity 97.35% 95.07% 99.38% Package Each test is individually boxed Specimen Nasal Swab Storage 2-30 Celsius Test Time 15-30 minutes CE Marked US FDA MHRA Compliant European Commission

Sugentech SGTi-flex COVID-19 Ag is an immunoassay for qualitative detection of Nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal and nasal swab specimen. • Specimen: Nasopharyngeal (or Nasal) swab • One Step, Fast results within 15 min • Full package for the whole test procedure, No need for additional tool/device - Swab - Buffer - Test Cassette • Package: 2 test kits *all prices are ex vat * shipping is free on orders over 1000 units to one location Product No. CAGT001E0 Description COVID-19 Antigen Lateral Flow Test. For self-testing only. Approvals CE Marked, MHRA registered Intended Use An immunoassay for qualitative detection of Nucleocapsid protein antigen from SARS-CoV-2 in nasal swab specimen. Accuracy Overall Accuracy Sensitivity Specificity 97.35% 95.07% 99.38% Package Each test is individually boxed Specimen Nasal Swab Storage 2-30 Celsius Test Time 15-30 minutes CE Marked US FDA MHRA Compliant European Commission

The Humasis COVID-19 Test is an in vitro diagnostic test based on lateral flow chromatographic immunoassay intended for qualitative detection of SARS-CoV-2 antigen in human nasopharynx. For healthcare professional use in near patient testing environments. Sensitivity 95.5% & Specificity 100% Kit Contents ▪ 1 x Test devices packaged individually in aluminium pouch ▪ 1 x Disposable test tubes with extraction buffer ▪ 1 x Filter caps ▪ 1 x Sterilised swabs for specimen collection ▪ 1 x Instructions for use *All prices are ex vat *£2 ex vat per test * shipping is free for orders over 1000 units

The Humasis COVID-19 Test is an in vitro diagnostic test based on lateral flow chromatographic immunoassay intended for qualitative detection of SARS-CoV-2 antigen in human nasopharynx. For healthcare professional use in near patient testing environments. Sensitivity 95.5% & Specificity 100% Kit Contents ▪ 25 x Test devices packaged individually in aluminium pouch ▪ 25 x Disposable test tubes with extraction buffer ▪ 25 x Filter caps ▪ 25 x Sterilised swabs for specimen collection ▪ 1 x Instructions for use *£2 ex vat per test *All prices are ex vat and shipping costs Certificates: FDA European Commission CE Marked Porton Down DHSC Manufacturer Humasis Co., LTD, South Korea EN ISO 13485:2016 Detection COVID-19 Antigen Method Immunochromatographic Assay Test Type Cassette Package 25T/Kit Specimen Nasopharyngeal or Nasal Swab Shelf Life 18 Months Storage 2-30 Celsius Test Time 15 minutes Cat No. ACOVA-7025

Antigen Diagnostic Kit Rapid test kit results in 20 minutes Used at the point of care by medical professionals

Ce système tout-en-un sans bandelettes dispose de 50 tests sur un ruban continu et d'un autopiqueur intégré contenant une cartouche de 6 lancettes. Avec ce système unique il ne faut plus s’inquiéter de manquer de bandelettes ou de lancettes. Des mesures faciles et rapides en seulement 4 étapes simples.

1ml - 2ml - 3ml - 4ml - 6ml - 9ml - 10ml Vacusera Serum Clot Activator Tubes are used for clinical biochemistry and immunology. The inner wall of the Serum Clot Activator Tube is specially coated with clot activator, which activate coagulation process. Vacusera Serum Separator Tubes contain inert gel; during centrifugation, gel forms a stable barrier between serum and blood cells.

The Lyme IgG/IgM Rapid Test Cassette is a qualitative test kit. Detects IgG and IgM antibodies to Borrelia in whole blood, serum or plasma specimens. This test consists of two components, an IgG component and an IgM component. GP Medical Professional Testing Kits CE Marked for Professional Use

Diagnostic Automation offers a One-Step Malaria Rapid diagnostic Test for Malaria pf and pv antigens. This Malaria Rapid Test is a rapid, qualitative test for the detection of Plasmodium falciparum and/or Plasmodium vivax in whole blood. For the rapid qualitative determination of Malaria P. falciparum pecific histidine rich protein-2 (Pf HRP-2) and Malaria P. vivax specific lactate dehydrogenase (pvLDH) in human blood as an aid in the diagnosis of Malaria infection. Diagnostic Automation offers two formats of the Malaria Rapid Test.

Diagnostic Automation offers a One-Step Malaria Rapid diagnostic Test for Malaria pf and pv antigens. This Malaria Rapid Test is a rapid, qualitative test for the detection of Plasmodium falciparum and/or Plasmodium vivax in whole blood. For the rapid qualitative determination of Malaria P. falciparum pecific histidine rich protein-2 (Pf HRP-2) and Malaria P. vivax specific lactate dehydrogenase (pvLDH) in human blood as an aid in the diagnosis of Malaria infection. Diagnostic Automation offers two formats of the Malaria Rapid Test.

The FlowFlex Rapid Lateral Flow Antigen Test Kit uses the latest patented technology to detect proteins, ensuring that it can detect new strains of the COVID-19 virus. Using a simple nasal swab within 2cm of the nose makes it extremely easy to administer an accurate test.

With the dual chamber PPM leak test stand, Poppe + Potthoff Maschinenbau offers a powerful system for testing sensors in medical device industry. The test stand can be implemented in R&D processes, but also during production as an end of line test. With pressures of up to 50 bars this equipment offers a large spectrum of testing opportunities in the medical area. Some Global Test Standards include: ISO 14644 ASTM G122-96 ASTM D6361 SAE AMS 0302 The PPM leak test stand is able to be programed to the customers requirement. The powerful in house built software enables exact design of pressure curves, such as holding times and exact pressure increase over time. It is an ideal solution for any sorts of plastic components. This exemplarily displayed test bench can utilize air or nitrogen as a test medium. Please get in touch about any other test mediums. In addition the PPM test benches can perform tests of multiple test units at a time.

Axon' has developed picocoax® a complete range of miniature coaxial cables and harnesses for applications where a large number of signals have to be transmitted with no interference. They can be used for measurement equipment and medical devices. Picocoax miniature coaxial cables offer a good compromise between small diameter (for example 0.20 mm) and capacitance of 50 to 100 pF/m. Picocoax® miniature coaxial cables are made with silver plated copper alloy conductor and high performance dielectric materials including FEP or Celloflon (porous PTFE patented by Axon'). Axon' also offers multipicocoax made with bundles of 18 to 304 picocoax cables. These composite cables are very flexible.

Spiral cables and cords axospiral® can be used for any electrical connection involving portable devices and moving equipment where flexing would cause damage to conventional wire and cable constructions. Axospiral composite cables have many advantages : flexibility, space saving, resistance to heat, chemicals, solvents. Axospiral wires and cables insulated with FEP, PTFE, ETFE, PFA, polyimide, vitax™, PU, ... dependent on the application. They can be overmoulded or terminated with different types of connectors. Axopiral composite cables and cords can be used for various applications: medical instrumentation, computer printers, robotics, test equipment.