General Information
Arnitel® is a family of high-performance copolyester-based thermoplastic elastomers (TPC) offering a unique combination of flexibility, chemical resistance and high-temperature performance.
Its unique chemistry consists of hard and soft segments which offer a great degree of design flexibility. This includes proven performance in breathable monolithic films, kink-resistant tubing, soft touch applications, and a variety of other innovative solutions for the medical industry.
Because of Envalior’s global commitment to manufacturing quality, medical industry leaders trust Arnitel® when material quality and purity is essential for demanding high-precision components.
Regulatory Affairs
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Absence Declaration BNST2023-11-16
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Absence Declaration Biocidal Products2023-11-16
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Absence Declaration DMF (2009/251/EC: Dimethylfumarate)2023-11-16
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Absence Declaration ELV (2000/53/EC: Heavy metals)2024-02-15
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Absence Declaration EPA 20 High Priority Substances 20192023-11-16
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Absence Declaration Food Allergens2023-11-16
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Absence Declaration NMP (N-Methylpyrrolidone)2023-11-16
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Absence Declaration Nano Materials2023-11-16
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Absence Declaration Ozone Depleting Chemicals2024-06-27
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Absence Declaration PAH (Polycyclic Aromatic Hydrocarbons)2023-11-16
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Absence Declaration PBT chemicals under TSCA section 6(h)2023-11-16
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Absence Declaration PFAS2024-03-05
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Absence Declaration POPs (Persistent Organic Pollutants)2024-09-04
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Absence Declaration Phthalates (2005/84/EC: DEHP, DBP, BBP,DINP,DIDP, DNOP)2023-11-16
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Absence Declaration Red Phosphorus2023-11-16
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Absence Declaration opBDE (2003/11/EC: Octa- / Pentabromodiphenylether)2023-11-16
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CALIFORNIA PROPOSITION 65 (INDUSTRIAL USE)2024-01-02
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Compliance Statement EU Sanctions and Embargos2024-05-16
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Deforestation Statement, Regulation (EU) 2023/1115 (EUDR)2024-09-19
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EU Medical Device Regulation2024-02-29
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Food Contact Canada Information (LONO)2024-11-06
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Food Contact Declaration Europe Arnitel®2023-11-10
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Food Contact Declaration MERCOSUR Arnitel®2024-06-27
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Food Contact Declaration USA Arnitel®2023-11-21
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Food Contact India Information Letter2023-05-11
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Food Contact Singapore Information Letter2024-02-15
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ISO 10993-10(-23) DECLARATION2023-12-20
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Information Letter European Pharmacopoeia2022-12-19
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Packaging Declaration EU Decision 97/129/EC (labelling)2024-04-17
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Packaging, Packaging Waste and CONEG declaration (94/62/EC)2021-12-06
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REACH Registration Statement2024-03-27
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REACH STATEMENT KOREA2023-11-16
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REACH STATEMENT TURKYE2023-11-16
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RoHS Statement (2011/65/EC: Heavy metals)2024-02-01
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SVHC, REACH Annex XIV and –XVII Statement2024-11-08
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United States Pharmacopeia (USP) declaration2022-12-19
Processing technology
Injection Molding