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certificates

Quality assurance – Certificates – Tests

All RFX+Care Outdoor products comply with and even exceed current international CE standards and regulations.

For Medical Device products, such as first aid kits, plasters, and bandages, the company produces and
distributes in accordance with ISO13485:2012: Medical Device, Quality Management Systems,
Requirements for Regulatory purposes. Our QC includes 100% in-line inspection using running cards anda numbering system as well as 100% final inspection. All our products are needle inspected through metal detectors.

The company applies the Environment Management System ISO14001:2004 in respect of production and sales of first aid kits and reflective vests.

Oppenhejm & Jansson  / RFX+care manufacturing Co. Ltd. work closely with TÜV SUD to check, test and certify all its medical device products, and with TÜV Rheinland for its reflective products in accordance with standard EN20471, EN1150 and ANSI. Oppenhejm & Jansson  / RFX+care manufacturing Co. Ltd. has undertaken tests in Intertek, SGS and other qualified testing laboratories to ensure that the raw material and finished products meet environmental standards and are safe and functional. Oppenhejm & Jansson  / RFX+care manufacturing Co. Ltd. medical device products, first aid kits and plasters are CE certified by TÜV SUD in Europe, registered in FDA USA and China, as well as TGA Australia.

All listed products can be freely sold / distributed in countries that adhere to these standards.

Oppenhejm & Jansson reflective products are tested and CE certified by TÜV and SP Technical Research institute of Sweden in accordance with the European EN13356 standard for personal safety devices.

European manufactured vests are CE certified by TÜV in accordance with EN1150 standard for non-professional use as well as EN ISO 20471:2013

All certificates and test reports are available on request