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Medical device - Import export

GermanyStuttgart, Freiburg and Baden-Wurtemberg

Germany

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We have been designing and producing UL labels for well-known industrial companies since 1990. The requirements and regulations are very complex and may require a detailed consultation in order to explain the UL-compliant marking and the different application programs. The UL certification of an end product by an OEM (Original Equipment Manufacturer) refers to every single component of the product. A label is such a component whose requirements are regulated in the UL 969 “Standard for Marking & Labeling Systems”.

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Germany

Optima Life Science's rotary 4SS Pouch Packaging Machine seals medical and diagnostic devices into pouches. Application examples: Wound Care Dressings Oral Filmstrips (Oral Dispersible Films) Oral transmucosal drug delivery Diagnostic Devices Drapes Transdermal Patches Sutures Optima with headquarters in Schwaebisch Hall, Germany, teams with its subsidiaries to design and build packaging equipment for pharmaceutical, consumer, nonwoven and life science products – from single standard machines to complete complex turnkey systems. Whether custom solutions or modular standard units, functions are consistently tailored to the specific needs of the customers and their industries. Optima is the worldwide leader in packaging technologies for many fields.

Germany

Alternatively to 4 Side Seal Packaging Machine rotative OPTIMA 4SS, Optima Life Science offers reciprocating platen sealing machines, which pack medical, pharmaceutical or diagnostic devices into pouches at high production speeds. Application examples: Wound Care Dressings Oral Filmstrips (Oral Dispersible Films) Oral transmucosal drug delivery Diagnostic Devices Drapes Transdermal Patches Sutures Optima with headquarters in Schwaebisch Hall, Germany, teams with its subsidiaries to design and build packaging equipment for pharmaceutical, consumer, nonwoven and life science products – from single standard machines to complete complex turnkey systems. Whether custom solutions or modular standard units, functions are consistently tailored to the specific needs of the customers and their industries. Optima is the worldwide leader in packaging technologies for many fields.

Germany

Maxcert is offering EC Representative services for non EU medical devices manufacturers. Maxcert is authorized/ registered EC REP service provider and can manage your ECREP requirements better than others. We make sure that you are MDR ready! and well updated with the EU regulations for your medical devices. Maxcert’s team has expert knowledge to help you navigate through the complex regulatory challenges that the new EU MDR bring. We can assist you through out the entire process to ensure that you and your business are compliant with all of the EU MDR requirements. For more information, reach out to us at

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