Sinapi biomedical (Pty) Ltd is an ISO13485 accredited company. Our notified body is SGS:UK and Authorised Representative in Europe is Mdi-Europa. ETO sterilisation is done on site.

The Sinapi Chest Drain range, Sinapi Urinemeter and the Medi-Safe safety scalpel are all CE marked according to Directive 93/42/EEC

Sinapi is registered with the FDA as contract manufacturer and regularly exports products to the USA, Germany, Austria, Spain, Greece, Turkey, Poland, Czech Republic, Romania, Southern Africa, the Far East, etc.

 

ISO 13485 and ISO 11135 Certificate 2019
CE certificate June 2020