HTL-STREFA

provements 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. 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. Our product categories:
• Safety lancets,
• Pen needles,
• Personal lancets,
• Lancing devices. At the moment, the Company has two modern production facilities in Poland (Lodz Special Economic Zone), as well as two sales and marketing offices located in Warsaw (Poland) and Marietta (GA, USA). HTL-STREFA works in close cooperation with its customers and end users to meet the market requirements exactly. 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-STREFA 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. To ensure 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, producing more than 50% of safety lancets worldwide. For years, our brand has been fulfilling the promises made to patients and health professionals, and has never failed. Since inception, HTL-STREFA has maintained and improved the quality management system in accordance with PN-EN ISO 13485:2012 and CAN /ISO 13485:2003 rules. All products are CE marked conforming with 93/42/EEC directive requirements for medical devices. DEKRA is our certifying entity. HTL-STREFA products are sold in over 80 countries – including restrictive markets like Brazil, US, Canada, China and Japan. We have received full approval/authorization from:
- FDA in the Unites States
- J-PAL in Japan
- K-FDA in Korea
- Anvisa in Brazil
- the European Union