Manufactured across a global network of ISO 13485 facilities, they meet or exceed requirements for regulations such as USP Class VI, ISO 10993, USP 661, and ICH Q3D. Like other Mevopur formulations, they are manufactured in dedicated ISO 13485 facilities and supported by testing to ISO 10993-1, USP, European Pharmacopeia, and ICH Q3D guidelines. They are offered in pre-colored or concentrate form in a range of vivid opaque and transparent colors that are fully bio-compatible per ISO 10993 standards to provide ultra-high-heat resistance and performance without compromising safety.

Global ISO Certificate Library

These colorants and additives are pre-certified to meet USP Class VI or ISO 10993 biocompatibility testing for global healthcare applications, such as medical devices, pharmaceutical, and health & wellness products. We can now offer expanded resin families that incorporate biocompatible functional additives, in both masterbatch and compounded forms, that meet or exceed industry standards for USP Class VI or ISO 10993 biocompatibility testing.”

Version / Date: 1 (no adjustments) / 30.12.2024 Page 1 of 2 ISCC PLUS Certificate Certificate Number: ISCC-PLUS-Cert-PL214-26100824 Bureau Veritas Polska Sp. z o.o. ul. Version / Date: 1 (no adjustments) / 30.12.2024 Page 2 of 2 Annex I to the certificate: Sustainable materials handled by the certified site (This annex is applicable for all scopes except of Trader, Trader with storage, Warehouse, Logistic centres, MTBE and ETBE) This annex is only valid in connection with the certificate: ISCC-PLUS-Cert-PL214-26100824 issued on 30.12.2024 Input material Output material Add-ons (voluntary)1) Raw material category2) SAI FSA3) FEFAC4) Polypropylene (PP) Plastic Compounds (PP) NO Bio Bio-circular Circular N/A N/A Polyethylene (PE) Plastic Compounds (PE) NO Bio Bio-circular Circular N/A N/A 1) ISCC PLUS add-ons (voluntary application, see www.iscc-system.org for further information): • 202-04: Food Security Standard • 205-02: Consumables • 202-07: Low ILUC-risk feedstock • 205-03: Non GMO for food and feed • 205-01: GHG emission requirements • 205-04: Non GMO for technical markets 2) Bio raw materials complies with the ISCC Principles 1 – 6 for the cultivation and harvesting of sustainable biomass.

Produced under rigorous cGMP and medical manufacturing protocols, the new amber color concentrates are made in three dedicated EN ISO 13485-2016 registered facilities using only medical-grade ingredients. They are formulated without animal-derived substances and phthalates, and have been pre-tested for compliance with: •    ISO 10993-1 and USP parts , (including class VI) •    European Pharmacopoeia, monograph 3.1.15 •    USP and •    elemental analysis, as per ICH Q3D

All materials in this range are formulated to comply with ISO 10993-4 and -5, REACH SVHC, and RoHS.   All the materials are manufactured in ISO 13485-2016 certified sites and supported by testing to ISO 10993-1, USP, EP, and ICH Q3D protocols.

Global ISO Certificate Library

Global ISO Certificate Library

PDI is accredited under ISO 17025 by A2LA (the American Association for Laboratory Accreditation) to perform testing as an independent laboratory body. Global ISO Certificate Library

Biocompatibility: Our PEEK solutions have passed ISO 10993 biocompatibility testing, ensuring safety and reliability for medical applications. Passed ISO 10993 biocompatibility testing, suitable for medical use