The Condoms manufactured by the company has been traced to Class II (b) stipulated in Annex IX of the Medical Devices Directive (MDD 93/42/EEC) dated 14 June 1993.

Directive 93/42/EEC covers the placing on the market and putting into service of Medical Devices Kros- M

The KROS-M products meet all of the relevant Essential requirements contained in Annex II of the MDD.

This will included amongst others, as relevant:

Risk management

Clinical data

Manufacturing

Final Inspection

Labelling and instructions

Quality Charter

Kros-M reputation for fault-free products is not the result of mere chance but of exacting manufacturing processes and a strict programme of tests and quality checks. Such perfectionism has not gone unnoticed, and the company is proud of its CE credentials together with its ISO certifications.

International Standard ISO 4074:2002 for rubber latex male condoms, requirements and test methods.

ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes.

ISO 2859-I:1999 defines the Sampling procedures for inspection by attributes; Part 1: sampling plans indexed by acceptable quality level (AQL) for lot-by-lot inspection.