Which regulatory certifications does Angiplast hold for export markets?

Angiplast operates an ISO 13485 certified quality management system. Products carry CE marking under the applicable European conformity route, and selected device families hold US FDA 510(k) clearance. Free Sale Certificates, ISO 9001 documentation and product-specific technical files are issued to support importer registration and tender submissions.

What is the minimum order quantity for OEM and private-label medical disposables?

OEM and private-label minimum order quantities are defined per device family and typically start at one full production lot per SKU. Artwork, pouch and carton printing, multilingual IFUs, UDI barcoding and customised kit configurations are handled in-house by the Angiplast CDMO team.

How are Angiplast single-use devices sterilised and validated?

Devices are assembled in a Class 10,000 clean room and sterilised in the company's in-house ethylene oxide (ETO) plant. Every batch is released against validated sterilisation cycles, bioburden and residual testing, leak and tensile testing, and documented traceability from resin lot to finished pouch.

Which countries does Angiplast currently supply?

More than 80% of Angiplast production is exported. The company serves distributors, hospital groups, government tenders and pharmaceutical partners across more than 52 countries in Africa, Latin America, the Middle East, South-East Asia, CIS and Europe.

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