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Medical Equipment
Technology with Kolplast DNA: Simple, Efficient, Reliable. The best solutions for your practice and patients.
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Hospitals

Make it better, faster and safer. Use Kolplast disposable kits for minor surgical and pre-surgical procedures.

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Our history


Kolplast was established in 1988 in Sao Paulo, Brazil, by a doctor who was tired of cleaning and sterilizing the vaginal speculums used in his own office.
Over all these years, the company built a very strong brand awareness among gynecologists and nowadays Kolplast is synonymous of Disposable Vaginal Speculum.
Our history, as shown by the milestones below, has an unmistakable thread of innovation.

  • 1988: Kolplast launches the first disposable Vaginal Speculum in Brazil;
  • 1990: Kolplast entered the proctology market launching disposables Anuscope and Rectosigmoidoscope;
  • 1998: Kolplast earns ISO 9002 Quality Certificate for disposable medical devices;
  • Kolplast supplies 5 million kits to the 1st National Campaign for Cervical Cancer Prevention promoted by the Brazilian Ministry of Health;
  • 1999: Kolplast acquires CE Mark for all its non-sterile products;
  • 2001: Kolplast supplies 4 million kits to the 2nd National Campaign for Cervical Cancer Prevention promoted by the Brazilian Ministry of Health;
  • 2004: Kolplast becomes the official partner and distributor of Hologic, North American company specialized in items for Woman Heath;
  • 2005: Kolplast achieves the following quality certificates:
  • Brazilian Good Manufacturing Practices (GMP) - RDC 59;
  • ISO 13485: 2004 for manufacturing and trading medical devices;
  • CE Mark for sterile products;
  • 2009: Kolplast launches the revolutionary Kolplux, the first Light System for the disposable Collin Vaginal Speculum;
  • 2010: Launch of Kolplast’s Colposcopes line;
  • 2014: Launch of Kolplast’s Electronic Medical Devices

MISSION, VISION AND VALUES


Mission


Meet our customers’ expectations and stay competitive through:

  • Diversified product portfolio;
  • Efficient industrial and commercial processes;
  • Fair relation of Price vs. Quality;
  • Constantly qualified services;
  • Harmonious relationship with our trading partners.

Vision


Kolplast to be recognized as:

  • Innovative Company;
  • Manufacturer of top quality health products;
  • Leader in the market segments in which it operates.

Values


  • Work as the only ethical means to achieve success.
  • Education as an instrument to face market challenges.
  • The Quality of our products and services must be world class standard.
  • The sense of urgency must be present in all actions aiming our customers’ satisfaction.
  • Organization, to be used as a tool of efficiency, expressed by, "A place for each thing, each thing in its place."
  • Profit as the natural result of the above principles, when applied to business operations.

Why choose Kolplast?


  • Provides the best solutions materialized in products;
  • Reliable and uncomplicated customer service;
  • Products and services in constant development;
  • Well respected Brand;
  • National reference within its markets;
  • National reference within its markets;
  • World class quality standards;
  • Provides fair and consistent prices;
  • Has all Healthcare regulatory approvals and Quality Certificates;
  • Exports to several countries around the globe, including the European Community;

QUALITY CERTIFICATES


02

NBR ISO 9001: 2008 - Quality Management System


A Quality Management System implementation represents a powerful tool enabling optimization of several processes within the organization. On top of these gains, it makes clear the commitment to continuous improvement of the products and services provided.
Kolplast is certified since 1998.

03

NBR ISO 13485: 2004 - Products for Health - Quality Management Systems


This International Certificate specifies requirements for a quality management system in which an organization must demonstrate its ability to provide health products and services that consistently meet customer and regulatory requirements.
Kolplast is certified since 2005.

01

INMETRO - Electronical Medical Devices


Product certification as Ordinance No. 350 of INMETRO - Conformity Assessment Requirements for Electrical Equipment under the Brazilian Health Agency, which specifies technical requirements for safety testing and electro medical equipment certification.
Kolplast has certified products since 2011.

04

FDA CERTIFICATION


Product certification issued by FDA - US Food and Drug Administration (American Regulatory Agency) for commercializing Health Products in USA.
Kolplast has certified products since 1997.

05

CE MARKING


Product certification according to 93/42/EEC Directive - Directive for Medical Devices, aiming commercialization of Health Products in Europe.
Kolplast has certified products since 1998.