Sinapi biomedical (Pty) Ltd is an ISO13485 and ISO9001 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 range 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
ISO 13485
ISO 9001
ISO 9001
CE certificate June 2016