HTL-Strefa S.A.
HTL-STREFA S.A. a company of MTD Medical Technology and Devices , is a world-leading medical device company that develops manufactures and sells safety lancets, personal lancets, and pen needles for insulin injection. Our modern manufacturing process and nearly 20 years of experience on the global market allows us to successfully ensure safety and convenience. We employ a continuous improvement strategy to analyze and update products, implementing improvements and launching new solutions to meet the changing needs of both patients and health care professionals. We aim to fulfill the most restrictive hygienic and sterility standards. The design of our products is defined by ergonomics, simplicity and reliability. To consistently provide safety for medical personnel and comfort for patients across the world by leveraging our expertise, advanced technology and innovative thinking.
Company details
Find locations served, office locations
- Business Type:
- Manufacturer
- Industry Type:
- Medical Equipment
- Market Focus:
- Globally (various continents)
About us
HTL-STREFA is focused on strategic manufacturing for top multinational medical corporations; we also sell our own products under the HTL-STREFA brand in cooperation with local distributors.
HTL -STREFA products are used in various diagnostic tests performed by hospitals, clinics and laboratories. The company also produces personal lancets used by diabetics as well as disposable pen needles for insulin injections, compatible with most pens available worldwide.
HTL products and their patented technology have been developed for patients, as well as their comfort and ease of use.
HTL-STREFA constantly develops, tests and manufactures new products to meet the new trends in diagnostics. The company achieved its success through the high quality of its products that meet international quality standards and take into account the individual needs of customers and requirements of dynamically developing markets.
The company is constantly investing in research and development. Its international team of engineers is always striving to create new solutions for patients and medical personnel, as well as innovative manufacturing technologies on a large scale to reduce the costs of supplied medical devices.
For the best quality of our goods, we constantly test our products according to international quality standards. Perfection, which accompanies the production from the assumptions phase to the delivery of the finished product to the customer in any part of the world, makes the products provided by HTL-STREFA increasingly popular every year.
Every day, nearly 10 million products are shipped from HTL-STREFA plants. Thanks to the highly developed distribution network, safety lancets, personal lancets and insulin pen needles carrying the HTL-STREFA logo, or under our Customer’s brand, can be in all continents.
HTL STREFA is a brand with global experience from more than 80 countries. We are the leading provider globally of blood micro-sampling medical devices, with close to 50% global market share in safety lancets (#1 position globally) and approximately 15% global market share by volume in personal lancets. For years, our brand has been fulfilling the promises made to the patients and health professionals, and has never failed.
Our Mission
To consistently provide safety for medical personnel and comfort for patients across the world by leveraging our expertise, advanced technology and innovative thinking.
Quality Standards
Since its very foundation, HTL-STREFA has maintained and improved a quality management system. The quality management system we have now implemented complies with the EN ISO 13485:2016 standard requirements. All products are CE marked conforming with 93/42/EEC directive requirements for medical devices. DEKRA is our certifying entity (http://www.dekra-certification.com).
Since January 2019, HTL-STREFA holds Medical Device Single Audit Program Certificate (MDSAP), confirming compliance with ISO 13485:2016, and the regulatory requirements of five different jurisdictions: Australia, Brazil, Canada, Japan and the United States.
HTL-STREFA products are sold in over 80 countries – including restrictive markets like Brazil, US, Canada, China and Japan.
We hold registrations and marketing authorisations issued by competent authorities and government agencies and certificates of conformity issued by accredited notified bodies allowing us to place the medical devices on the market and put them into service, without limitation:
- FDA in the Unites States
- TGA in Australia
- Anvisa in Brazil
- HC in Canasa
- MHLW in Japan
- MFDS in Korea
- COFEPRIS in Mexico
- UKRMEDCERT in Ukraine
- DEKRA Certification B.V. in the European Union
Ethics
HTL-STREFA is consistently providing safety for medical personnel and comfort for patients across the world by leveraging our expertise, advanced technology, and innovative thinking. HTL-STREFA, by promoting unique and effective solutions related to public health, focuses on business development considering the values of social, ethical, and environmental responsibility. HTL-STREFA develops its activities in a responsible and sustainable way. Ethical business practices are an integral part of our activity – now and in the future. We are committed to conducting our business as responsible corporate citizens, in an honest and ethical manner, in compliance with all applicable laws.
History
2000:
- Founding of the Company under the name HTL-STREFA
- Opening of first manufacturing plant within the Lodz Economic Zone
- High-volume production of safety lancets for the global market
DEVELOPMENT:
2007:
- Launch of second production facility with own needle grindery
- Acquisition of significant Swedish competition – Haemedic AB
- Establishment of US subsidiary – HTL-STREFA, Inc. based in Marietta, GA, USA
EXPANSION:
- Two modern production facilities in Lodz Special Economic Zone, Poland
- Two Sales & Marketing offices in two locations (Warsaw, Poland and Marietta, GA, USA)
- 5 product categories with multiple variations
- Introduction of new innovative solutions into the market
- Global market presence – more than 80 countries around the world