Government of Pakistan Ministry of National Health Services Regulation & Coordination Drug Regulatory Authority of Pakistan FORM-8A, [300 rate 15(5)] LISTMENT_OR REGISTRAT! \CCESSORY OR COMPONENT FO! CERTIFICATE OF EN! VICE Licence No, ELI-00249 2311212022 12-31/2017-MD Mis Interex Company House No 195, 2nd Floor, KMCHS, Near Hill Park, Karachi Godown Address: Same as above ‘The medical device as per details given below has been registered or enlisted under the DRAP Act, 2012 and the rules made there-under subject to the conditions appearing hereinafter: Enistmend Nane of Bret Class Shatite Registration medical desertion Ne device or accessory o component a) (2) @) (4) ©) MDIR-0004375 KORA 250 DR ‘Dual chamber rate responsive oO 24 months Pacemaker TPMO10C | pacemaker MRI conlionel (Qual chamber rate |(M-51) responsive pacemaker MRI conditional) [TPMo10) MDIR-0004376 [KORA 250 SR | Single chamber rate responsive D +24 months Pacemaker TPM013C | pacemaker MRI conditional (ingle chamber rate |(M-51) responsive pacemaker MRI conditional). [TPMo13¢) 8. ‘ier re OE han Name and complete address of manufacturer: eau ston ONC) Set Mis MicroPort CRM Sr. Couch @9ule ang men of ancerttion Via Crescentino s.n. 13040 Saluggia (VC) Italy amabad, 2 ‘This enlistmentregistration shall be valid for a period of five years from the date mentioned above unless rug Regulatory Author of Pakistan -TF Complex GV, islamabad Pakistan -Ph, +8251 $262180, 08, 492.51 9107402 Page 1/2ES 4 ¥ & rer suspended or cancelled, 3. Thename shallbe changed incase ithas resemblance with already enistedregistered medical device. 4, This enlistmenutegistration is subject to the conditions specified i ne ert specified in the DRAP Act, 2012 and the rules made Renewal Date: 22/12/2027 ' ” OW 2b, A * sono Kn Secretary oS fa ny eee [Device Board een Seat brug Regulatory Authority of Pakistan «TF Complex G8/4, Islamabad Pakistan -Ph. +92 81 9262180, 051, 82.1 9107402 Page 22