https://www.avient.com/sites/default/files/2022-03/MEVOPUR Chemical Foaming Agents Application Bulletin_JP.pdf
a) 米国食品医薬品局(FDA)または国際標準化機構(ISO)により「インプラント」機器として分類される医療機器、または米国薬局方(USP)または ISO 規格で定義される「パーマネント」
機器、または
(b)EU指令90/385/EECの改正で定義された能動埋込型医療機器、または
(c)EU指令93/42/EECの改正で定義された「長期」使用のための医療機器。
https://www.avient.com/sites/default/files/2025-03/65536-Certificate-05MAR2024.pdf
Francisco Nakasato, Bairro São
Roque das Chaves 1700 Itupeva SP
13295-000 Brazil
Avient Belgium SA Design and manufacture of color and additive concentrates, thermoplastic
resins and specialty compounds
Rue Melville Wilson 2, B-5330
Assesse, Belgium
Magna Colours Limited The design, manufacture and distribution of specialty colouration products
and chemical auxiliaries for us in the textile, dying, printing and finishing
industries.
https://www.avient.com/sites/default/files/2022-07/MEVOPUR Chemical Foaming Agents Application Bulletin_CN.pdf
埃万特的产品不为以下目的或用途而设计,也不会宣传或预期用于以下目的或用途:
(a) 被美国食品药品监督管理局(FDA)或国际标准化组织(ISO)归类为“植入”类器械的医疗器械;或美国药典(USP)或ISO标准定义的“永久”使用器械;或
(b) 经修订的欧盟指令90/385/EEC中定义的有源植入式医疗器械;或者
(c) 经修订的欧盟指令93/42/EEC中定义的“长期”使用的医疗器械。
https://www.avient.com/sites/default/files/2022-05/MEVOPUR LQ for Silicone Elastomers_CN.pdf
埃万特的产品不为以下目的或用途而设计,也不会宣传或预期用于以下目的或用途:
(a) 被美国食品药品监督管理局(FDA)或国际标准化组织(ISO)归类为“植入”类器械的医疗器械;或美国药典(USP)或ISO标准定义的“永久”使用器械;或
(b) 经修订的欧盟指令90/385/EEC中定义的有源植入式医疗器械;或者
(c) 经修订的欧盟指令93/42/EEC中定义的“长期”使用的医疗器械。
https://www.avient.com/sites/default/files/2021-09/mevopur-colors-for-needle-hubs-bulletin-cn.pdf
埃万特的产品不为以下目的或用途而设计,也不会宣传或预期用于以下目的或用途:
(a) 被美国食品药品监督管理局(FDA)或国际标准化组织(ISO)归类为“植入”类器械的医疗器械;或美国药典(USP)或ISO标准定义的“永久”使用器械;或
(b) 经修订的欧盟指令90/385/EEC中定义的有源植入式医疗器械;或者
(c) 经修订的欧盟指令93/42/EEC中定义的“长期”使用的医疗器械。
https://www.avient.com/sites/default/files/2022-07/REMAFIN EP White Masterbatches for Pharma Application Bulletin_CN.pdf
埃万特的产品不为以下目的或用途而设计,也不会宣传或预期用于以下目的或用途:
(a) 被美国食品药品监督管理局(FDA)或国际标准化组织(ISO)归类为“植入”类器械的医疗器械;或美国药典(USP)或ISO标准定义的“永久”使用器械;或
(b) 经修订的欧盟指令90/385/EEC中定义的有源植入式医疗器械;或者
(c) 经修订的欧盟指令93/42/EEC中定义的“长期”使用的医疗器械。
https://www.avient.com/sites/default/files/2024-01/Global Standard Response_Dec 2023.pdf
Avient can provide its
NDA form upon request
https://www.avient.com/sites/default/files/2022-04/Avient Q1 2022 Earnings Release.pdf
You are advised to consult any further disclosures
we make on related subjects in our reports on Form 10-Q, 8-K and 10-K that we provide to the
Securities and Exchange Commission.
4
Non-GAAP Financial Measures
The Company uses both GAAP (generally accepted accounting principles) and non-GAAP
financial measures.
https://www.avient.com/sites/default/files/resources/POL%2520KeyBanc%2520IR%2520Presentation%2520w%2520non-GAAP%252009%252010%25202013.pdf
You are advised to
consult any further disclosures we make on related subjects in our reports on Form 10-Q, 8-K and 10-K that we provide to the Securities and Exchange Commission.
https://www.avient.com/sites/default/files/resources/POL%2520Gabelli%2520IR%2520Presentation%2520w%2520Non-GAAP%252003%252020%25202014.pdf
You are advised to
consult any further disclosures we make on related subjects in our reports on Form 10-Q, 8-K and 10-K that we provide to the Securities and Exchange Commission.