Muzamal Industries Sdn Bhd

1. The device conforms to the manufacturers quality system prior to release 2.The technical documentation and the EU declaration are drawn up and kept to date 3. The Post Market Surveillance obligations are complied with in accordance with Article 10(10) 4. The reporting obligations referred to in article 87 to 90 are fulfilled 5. In case of investigational device, the statement referred to section 4.1 of Chapter II of Annex XV is issued

1.The technical documentation and the EU declaration of conformity are drawn up and up to date 2.The post market surveillance obligations are complied with in accordance with article 10(10) 3.The reporting obligations referred to in article 87 to 91 are fulfilled