SPENCER, Mass.–(BUSINESS WIRE)–FLEXcon®, an innovator in adhering blanket and laminating, today appear the barrage of FLEXcon® MedFLEX™, a band of characterization substrates that meets all achievement belief appropriate by the Food and Drug Administration’s (FDA) proposed different accessory identifier (UDI) rule. The legislation will crave Class II and III medical accessories broadcast in the U.S. to backpack a different numeric or alphanumeric cipher with an identifier specific to anniversary accessory or archetypal as able-bodied as an identifier with accepted assembly information. The FLEXcon MedFLEX band is UL-certified in accordance with UL/IEC 60601-1 3rd copy business backbone rub tests. All articles are accessible for absolute UL adoption.
“The FDA’s awaiting legislation will alert added than 21,000 medical accessory manufacturers globally to abide an assay of their accepted practices to accommodated all requirements. This will accommodate investigations into another labeling abstracts and requests for accretion to amend absolute buys,” said Ken Koldan, new business development manager, FLEXcon. “The FLEXcon MedFLEX artefact band opens up new bazaar opportunities for converters and printers and gives them a arch alpha in carrying anon adoptable, UL-recognized characterization abstracts advised accurately for the medical accessory industry.”
In accession to the acceptance of abstracts that accede with UL/IEC 60601-1 3rd copy appearance backbone rub tests, and potentially UL-recognized materials, the FDA UDI aphorism will additionally crave specific advice and barcodes on all artefact labels. Manufacturers will additionally charge to advance the abstracts aggregate for clue and trace purposes. FLEXcon MedFLEX articles not alone accommodated these requirements, they advance FLEXcon’s high-performance acrylic adhesives and their best thermal alteration printable topcoats. Three of the articles are UL-recognized with inks and ribbons and all articles are anon adoptable into converters’ UL files. Articles include:
For specific artefact information, appointment www.FLEXcon.com/MedFLEX.
FLEXcon prides itself on carrying abundant added than avant-garde solutions. The aggregation additionally serves as a cardinal assistant to printers and converters, allowance them cross any new aldermanic or industry standards to ensure they accept every befalling to break advanced of bazaar demands and abound their businesses. FLEXcon’s continuing as a accustomed baton in affiliation with UL positions the aggregation as a admired ability for bigger compassionate of new regulations and acquiescence issues.
For added advice about FLEXcon chase us on Twitter. To break adapted on the latest developments on the FDA UDI ruling, accompany Ken Koldan and added industry leaders in the Different Accessory Identification LinkedIn group. You can additionally apprehend the absolute proposed aphorism by visiting www.fda.gov and accumulate up on the cachet at www.regulations.gov.
FLEXcon is an innovator in adhering coating, laminating and finishing of abiding abstracts acclimated in cartoon applications, electronics and new products. Through a ability of curiosity, adaptability and a drive for excellence, FLEXcon is the trusted accomplice to a advanced ambit of companies from printers and fabricators to engineers and designers developing articles for absolute and arising markets. Headquartered in Spencer, Mass. the aggregation has operations throughout North America and Europe with administration worldwide. For added information, appointment www.FLEXcon.com or alarm 1-508-885-8200.
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