SWISSMED VENTURES AG.

Located at
NEUGASSE 18 ,6300 ZUG ,Switzerland.

has been found to comply with
ISO13485:2016

For the following scope:

MANUFACTURER AND DISTRIBUTOR OF STERILE HEMODIALYSIS MEDICAL DEVICES

UNDER TRADEMARK BRAND NAME (RENOVA), STERILE HOLLOW FIBER

HEMODIALYZER (HEMODIALYZER FILTER), STERILE BLOOD LINE TUBE, STERILE

HEMODIALYSIS FISTULA NEEDLES. RENOVA STERILE HEMODIALYSIS,

HEMODIALYSIS MACHINE, RENOVA HEMODIALYSIS MACHINE, RENOVA BICART

(BICARBONATE CARTRIDGE AND BAG FOR HEMODYALSIS MACHINES),ACID

CONCENTRATES & DIALYSIS SOLUTIONS( RENOVA CONCENTRATES & DIALYSIS

SOLUTIONS), RENOVA CONTINUOUS RENAL REPLACEMENT THERAPY CRRT &

RENOVA PERITONEAL DIALYSIS SYSTEM( RENOVA PERITONEAL DIALYSIS MACHINESWITH RENOVA PERITONEAL DIALYSIS SOLUTIONS

.

Certificate Issuance: 15.09.2025              1st Surveillance: 15.09.2026
Certificate Expiry:     15.09.2028             2nd Surveillance: 15.09.2027

Certificate No:QAMD20220755