Jokerµç×Ó

Jokerµç×Ó (Jokerµç×Ó) - Policy regarding Medical Device Applications of Jokerµç×Ó’s Products

Jokerµç×Ó seeks business relationships with customers who participate in the healthcare industry as a component supplier. As a matter of principal, our Medical Device Policy is that:

a) Jokerµç×Ó does not supply any products to be used in medical device applications that constitute a non-temporary implant (i.e., that, in whole or in part, may be in contact with a patient’s skin, body fluids or tissues for more than 29 days).

b) Jokerµç×Ó may supply products to be used in medical device applications where the medical device could be in contact with a patient’s skin, body fluids or tissues for a period of 29 days or less. Jokerµç×Ó only supplies customers with products for these types of medical devices in accordance with its medical contractual provisions, and where other specific corporate risk management conditions are met.

c) Jokerµç×Ó may supply products for use in all other medical device applications. Jokerµç×Ó will use its good business judgment to set specific Jokerµç×Ó corporate risk management conditions in such circumstances.

d) Jokerµç×Ó does not design, manufacture, test, and/or directly sell any medical devices. As a component supplier, Jokerµç×Ó may offer technical assistance to customers related to the performance and design using our materials only. If a medical device manufacturer chooses to use an Jokerµç×Ó component in a medical device, it remains the sole responsibility of the medical device manufacturer to test and validate the performance of their medical device for fitness in use and for compliance with all applicable medical device legal requirements. Jokerµç×Ó assumes no responsibility or liability for the medical device’s fitness in use or compliance with applicable medical device legal requirements.

e) Jokerµç×Ó has designated specific medical grade compositions for its products. Customers who intend to use Jokerµç×Ó products in a medical device application will only be supplied with these specific medical grade compositions. No other Jokerµç×Ó products may be supplied for use in medical device applications.

f) It is the sole responsibility of the manufacturer of the medical device to determine the suitability (including biocompatibility) of all new raw materials, products, and components, including any medical grade Jokerµç×Ó produces, in order to ensure that the final end-use product is safe for its end use; performs or functions as intended; and complies with all applicable legal and regulatory requirements.

g) It is the sole responsibility of the manufacturer of the medical device to conduct all necessary tests and inspections and to evaluate the medical device under actual end-use requirements and to adequately advise and warn purchasers, users, and/or learned intermediaries (such as physicians) of pertinent risks and fulfill any postmarket surveillance obligations. Any decision regarding the appropriateness of a particular Jokerµç×Ó material in a particular medical device should be based on the judgment of the manufacturer, seller, the competent authority, and the treating healthcare professional.

h) Unless Jokerµç×Ó expressly agrees by written contract, Jokerµç×Ó product names, trademarks and the Jokerµç×Ó name shall not be used with any medical devices, and customers should not represent to others that Jokerµç×Ó permits, recommends, or endorses the use of its products in any medical devices.

i) Jokerµç×Ó WILL NOT WARRANT THAT ITS PRODUCTS ARE SUITABLE FOR USE IN ANY MEDICAL DEVICE OR MEDICAL APPLICATION.