K2 Medical

A leader in medical devices
K2 Medical. A Kahma Group Division.

K2 Medical, a Kahma Healthcare Group Company, is a manufacturer and distributor of innovative, solution-orientated medical devices for the South African healthcare market. Our business is built on partnerships with international market leaders and our ability to develop and manufacture locally relevant brands and products. Our aim is to provide innovative, top-quality solutions, enhancing the lives of clinicians and patients. We do this by adding value to our customers through offering quality products and services, by consistently meeting our customers’ expectations and by promoting and adhering to sound ethical business practices.

K2 Medical website

Medical and Critical Care

  • Supplies a range of gold standard products from Pall Medical and Haemonetics, including a full range of blood and blood component filters, intravenous filters for both clear and TPN filtration, breathing filters and water filters, in South Africa and Sub-Saharan Africa.
  • Distributes Vernacare environmentally friendly systems for hospital human waste management.
  • Has a long-standing relationship with BD and is an accredited representative for various medical consumables in the BD portfolio.
  •  Locally assembles, manufactures, and sterilises Mantaflex transducer kits for haemodynamic pressure monitoring and has been a player in the South African health sector for more than 20 years.

Manufacturing and Assembly

K2 Medical also has the capabilities to provide a third-party manufacturing service in its accredited clean rooms. This includes turnkey manufacturing and packaging of medical devices for various markets in a dedicated clean room with an independent HVAC system and separate entrances.

K2 Medical actively seeks out new opportunities and partnerships with companies that can utilize the advantage of the clean room facilities and staff expertise to produce their products.

Surgical, Wound Care and Ultra Sound

  • Has represented the Mölnlycke Healthcare surgical portfolio since 2005 selling their gloves, drapes, custom procedure trays as well as their laparoscopic range of trocars and instruments.
  • More recently the Surgical, Wound Care and Ultrasound business unit has re-acquired the Mölnlycke market-leading wound care portfolio after having previously represented the brand.
  • Supplies the market-leading BK Ultrasound systems used in procedure-driven clinical specialities such as urology, general and neuro-surgery.
  • Also supplies DK Technology’s state-of-the-art MRI/fusion systems for prostate biopsies.

Mother and Baby

Mother and Baby Bags supplies maternity wards in the private hospital groups with quality products specifically designed for mothers who have just given birth. These bags bring all the essential supplies a mother and baby needs, conveniently to her bedside, in a single package.

K2 Medical clean rooms

K2 Medical assembles a range of products in its ISO 13485 accredited and validated clean rooms, including the assembly of custom-designed transducer and infusion lines. K2 Medical holds a valid SAHPRA licence for the manufacturing of Medical Devices.

Our clean rooms are situated on our premises in Midrand and comprise of 2 separate validated Clean Rooms:

  • ISO 7/8
  • ISO 6 with a ISO 4 compliant Unidirectional Air Flow (UDAF) System

Our trained and competent staff, are capable of assembling, packing and labelling of a variety of products requiring controlled environments including:

  • The assembly of orthopaedic devices
  • The packaging, sealing, and labelling of medical devices according to customer specifications
  • Onsite Terminal Ethylene Oxide sterilisation of packaged products
Why use our Clean Rooms?

The manner in which our clean rooms have been engineered allows them to maintain a very low concentration of airborne particulates. They are well-isolated, well-controlled from contamination, and actively cleansed. Our cleanrooms are designed to keep everything from dust, to airborne organisms, or vaporised particles, away from them, and so from whatever products are being handled inside them.

Both our cleanrooms are classified by how clean the air is, according to the particle quantity and particle size per cubic meter of air. Although several classifications exist, there has been an increasing trend to change from previous classification systems to the ISO classification system in ISO 14644-1.

The basis of cleanroom standards is the micrometer, micron (mm) in its abbreviated form.

The image below compares the size of a micron with that of a human hair (70 micrometers) and a grain of beach sand (90 micrometers).

How do we maintain the air quality in our Clean Rooms?

The most effective way of maintaining the air quality in our cleanroom is to operate and maintain them correctly by:

  • Minimising the amount of potential contamination that escapes from your manufacturing operations
  • Strictly controlling access to the cleanroom to only trained personnel and limiting the number, as even trained operators are the most significant source of cleanroom contamination
  • Regularly cleaning your facility to strictly controlled procedures
  • Regular maintenance of the facility and equipment
  • Regular monitoring of the air filters and air flows and frequent recertification of the cleanroom
Why would you need to use our Clean Rooms?

Maximising product yield, improving quality control and ensuring safety are common reasons to use our clean rooms.