Shanghai Sunland Industrial Co., Ltd is the top manufacturer of Personal Protect Equipment in China, with 20 years’experience. We are the Chinese government appointed manufacturer for government power,personal protection equipment , medical instruments,construction industry, etc. All the products get the CE, ANSI and related Industry Certificates. All our safety helmets use the top-quality raw material without any recycling material.
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We provide exclusive customization of the products logo, using advanced printing technology and technology, not suitable for fading, solid and firm, scratch-proof and anti-smashing, and suitable for various scenes such as construction, mining, warehouse, inspection, etc. Our goal is to satisfy your needs. Demand, do your best.
Professional team work and production line which can make nice quality in short time.
The professional team provides 24 * 7 after-sales service for you, which can help you solve any problems
Address：No. 3888, Hutai Road, Baoshan District, Shanghai, China
The Logix Smart™ Coronavirus Disease 2019 (COVID-19) Test ,kit, is an ,in vitro diagnostic, test that uses our patented CoPrimer™ technology for the qualitative detection of the RNA from SARS-CoV-2 coronavirus (COVID-19).. The test operates using a single step real-time reverse transcriptase polymerase chain reaction (RT-PCR) process in lower respiratory tract fluids (e.g. bronchoalveolar ...
9/1/2020, · Date: 7 August 2020Subject: Substandard/Falsified medical devices and personal protective equipment (PPE) used in the context of the COVID-19 pandemicWHO-identifier: 2020/3, version 1 Type of action: Advice to users of medical devices and PPE used for prevention, treatment and care for COVID-19.Attention: Users of medical devices and PPE, procurement entities and customs officials, …
Many microbiology and all microscopy products of Merck are “,in vitro diagnostic, medical devices” (IVD) according to the directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 and fulfill the requirements for CE self-certification.. ,Instructions, for Microbiology. We provide the general ,instruction, for use for dehydrated culture media and specific ,instructions, ...
Documents and Certificates related with our COVID-19 Antigen Test ,kits, can be downloaded as shown below: Certificate of EU product notification. Notify Form for ,In Vitro Diagnostic, Medical Devices (by EU Representative). Declaration of Conformity (DOC). ,Instruction, for Use (SARS-CoV-2 Antigen Rapid Test ,Kit,). Free Sales Certificate.
India regulate Import, Manufacture, Sale, Distribution and Clinical Performance of ,In-Vitro Diagnostic, Medical Devices under Medical Device Rules 2017, w.e.f 1 st January, 2018.. ,Diagnostic kits, manufactured in India require to obtain the license from State Licensing Authority (SAL) / Central Licensing Authority (CLA), depending upon their classification.
The ,In Vitro, Device Directive Article 1, point 2b defines an IVD as any medical device which is a • Reagent, Reagent Product • Calibrator, Control Material • ,Kit, • Instrument, Apparatus • Equipment, System Whether used alone or in combination, intended by the manufacturer to be used ,in vitro, …
intended use or purpose, as reflected in the specifications, ,instructions, and information provided by the product owner of the medical device. ,IN VITRO DIAGNOSTIC, (IVD) PRODUCT (as set out in the Regulations): means any reagent, reagent product, calibrator, control material, ,kit,,
expedite the availability of ,in vitro diagnostics, needed in public health emergency situations and to assist interested UN procurement agencies and Member States in determining the acceptability of using specific products in the context of a PHE, based on an essential set of available quality, safety and performance dat a.