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Our brands and certifications

CIZETA MEDICALI

Cizeta Medicali, specialist in elastic compression since 1872. The company designs and produces innovative solutions for the treatment of venous and lymphatic insufficiency.

Cizeta is also developping a new generation of patented orthotics endorsed by specialists in traumatology and rheumatology.

CIZETA MEDICALI is always looking to improve the quality of the medical service rendered by its products and has obtained certification in all certifying countries.

Originin : Italy

Certifications:

CE marking

Cizeta Medicali’s products are Class 1 medical devices and meet the requirements of EEC directive 93/42 as well as its successive modifications

Cizeta Medicali’s s quality management system conforms to the ISO 9001 and ISO 13485 standards. Thanks to this certification Cizeta Medicali is able to guarantee compliance with the strictest qualitative and regulatory standards for its products and services.

OEKO-TEX STANDARD 100

All Cizeta medicali’s stockings, A.T.E. stockings, arm sleeves and various compression devices are certified OEKO-TEX to guarantee they meet the regulatory thresholds for substances that may be harmful to human health (azo dyes, formaldehyde, heavy metals, etc.)

ASQUAL Approval – France

Certification issued by Quality Association ASQUAL which guarantees the correspondence of certified products to standards NF G30-102B guaranteeing their quality.

RAL Approval – Germany

Certification issued by the Hohenstein Research Institute which guarantees the quality of the stockings by conducting periodic quality tests in accordance with the rules RAL-GZ 387/.

Food and Drug administration (FDA) Approval – USA

Cizeta medicali’s products are approved by the FDA. The FDA is the agency of the Department of health and human services of the United States in charge of protecting public health and ensuring the safety as well as the efficacy or medical drugs and devices.

State Food and Drug Administration (SFDA) Approval – RD Chine
Cizeta Medicali products are approved by the SFDA (currently the National medical products administration) which is the Chinese government agency in charge of protecting public health as well as guaranteeing the safety and efficacy of medical drugs and devices.

EUROCOM (European manufacturers federation for compression therapy and orthopedic devices)
Cizeta Medicali is a founding member of Eurocom. Only the companies producing RAL-GZ 387/1 certified medical stockings can be member Eurocom. The objective of the Association is to promote the acknowledgement of RAL-GZ 387/1 certified stockings among all the actors in the healthcare sector and patients.

VARISAN

The Varisan Compression garment range is a CIZETA MEDICALI brand.

Manufactured in Italy according to the highest international standards, each garment is subjected to a meticulous quality check to ensure that only the best quality products are supplied customers.

The Varisan range includes everything from flight socks to arm sleeves to circular- and flat knit compression garments. It is the first compression garment range to introduce Standard Flat Knit sizes into the médical compression therpay market.

Origin: Italy

Certifications:

Corps du texte certifications: Varisan conforms to the standards of the certifications obtained by Cizeta Medicali :

CIZETA ORTÓ

The Cizeta Ortó range is a CIZETA MEDICALI brand.

Cizeta Ortó specializes in the treatment of musculoskeletal disorders of traumatic and rheumatological origin with a particular focus on the management of ankle sprains with A2T® and low back pain with the SL Range.

Certifications:

Corps du texte certifications: Cizeta Ortó conforms to the standards of the certifications obtained by Cizeta Medicali :

HOLLISTER

Hollister Incorporated is an independent, employee-owned company that develops, manufactures, and markets healthcare products and services worldwide.

Hollister offers advanced medical products for Ostomy Care, which includes two strong global brands – Hollister Ostomy and Dansac Ostomy; Continence Care; and Critical Care. They provide innovative healthcare programs and services, as well as educational materials for patients and healthcare professionals.

Hollister has been serving healthcare professionals and patients for more than 95 years — making a difference in the journey of life for people throughout the global community.

Certifications:

CE marking

Hollister’s products are Class 1 medical devices and meet the requirements of EEC directive 93/42 as well as its successive modifications.

Environmental responsibility

Several manufacturing and distribution facilities of Hollister have earned energy efficiency and sustainability certifications:

Ballina, Ireland Manufacturing Facility– accredited to ISO 14001:2015 and is regulated by Ireland’s Environmental Protection Agency to the highest international standards.
Bawal, India Manufacturing Facility– accredited to ISO 14001:2015.
Kaunas, Lithuania Distribution Center– certified for A CLASS designation.
Juliet, Tennessee, United States Distribution Center– LEED certification silver status.
Roosendaal, the Netherlands Distribution Center– BREEAM 3-star certified.

BURNSHIELD

Burnshield is a trademark of Levtrade International.

Widely known amongst emergency and first aid services, the Burnshield range offers natural hydrogel-based products for burn care. The Burnshield range includes:

Burn dressings available in several sizes to adapt to different burnt skin surfaces.
Hydrogel bottles.
Blankets for firefighter protection & the extraction of injured people from fire zones.
Special dressings (hydrogel jacket for children and face mask)
A wide range of first aid and trauma kits to suit the needs of individuals as well as professionals (factories, mines, military, restaurants and hotels, sports, health professionals, etc.)

Essentially composed of purified water, Burnshield hydrogel immediately soothes the heat induced by the burn, thus limiting the risk of hypothermia in severe burns. This cooling effect will result in slowing the development of the burn both on the surface and in depth, protect the skin nerve endings and minimize the traumatic risks of edema.

Burnshield hydrogel also provides long-lasting hydration of the coated surface which promotes cell renewal, prevents skin dryness and creates a favourable environment for healing.

The presence of Maleleuca Alternifolia (Tea Tree) essential oil allows Burnshield hydrogel to effectively protect the burn from the risk of infection; this is thanks to a single active ingredient: terpinen-4-ol.

Burnshield’s formula is non-stick, non-greasy, water soluble, hypoallergenic, non-toxic and non-irritant.

Burnshield is indicated for the emergency treatment of first to third degree burns regardless of the origin: thermal, chemical, electrical, laser, radiology and sunburn.

Clinical trials have also demonstrated the efficiency of Burnshield Hydrogel for the treatment of certain resistant skin irritations, circumcision wounds as well as diabetic foot wounds.

Burnshield products are exported to over 42 countries and used by many international organizations and institutions, some examples:

Italian Civil Defense and Navy
French civil defense and army
British Civil Defense
International Committee of the Red Cross
Jordanian Civil Defense
Euromarché’s subsidiaries in Saudi Arabia
Many airlines and airports around the world

Origin : South Africa

Certifications:

CE marking

Burnshield’s products are Class 1 medical devices and meet the requirements of EEC directive 93/42 as well as its successive modifications

ISO 13485:2016 et ISO9001:2015 certifiations

Burnshield’s quality management system conforms to the ISO 13485:2016 et ISO9001:2015 standards. Thanks to this certification Burnshield can guarantee compliance with the strictest qualitative and regulatory standards for its products and services.

Food and Drug administration (FDA) – USA

Burnshield’s products are approved by the FDA. The FDA is the agency of the Department of health and human services of the United States in charge of protecting public health as well as ensuring the safety and efficacy or medical drugs and devices.

Therapeutic goods administration(TGA) – AUSTRALIA

Burnshield’s products are authorized by the Therapeutic goods administration(TGA), the Australian government agency responsible for regulating the import, supply, manufacture, export and advertising of therapeutic goods.

SAHPRA/Medicines control council (MCC) – SOUTH AFRICA

Burnshield’s products are approved for sale in South Africa and meet all quality standards as well as the South African regulatory requirements for medical devices and products.

Canadian Medical Devices Conformity Assessment System (CMDCAS) – CANADA

Burnshield’s products are approved for sale in Canada and meet all quality standards as well as the Canadian regulatory requirements for medical devices and products.

Medical Device Single Audit Program (MDSAP)

Burnshield’s products conform with the MDSAP, an multinational certification protocol ensuring that a medical product or device meets the regulatory requirements of all member authorities (TGA Australia, Brazilian Agency for Sanitary Vigilance, Health Canada, Japanese Ministry of Health, National Agency for Japanese drug and medical devices and the FDA)

INTRA CATHETERS

With over 35 years of expericence Intra Catheters specialises in the production of special catheters for various specialties:

Anaesthesiological wards
Intensive care
Departments of internal medicine
Emergency medical care
Paediatry
Pneumology
Oncology
Vascular surgery
Electro physiology
Cardiology
Cadiology
Angiography

Origin : Germany

Mainat

Founded over 30 years ago, Mainat is a family business specializing in the manufacture of medical textiles. The Mainat product line includes:

Custom-made pressotherapy garments for treating burns, vascular disorders and Lymphoedemas.
Standard size pressotherapy garments for postoperative treatment after plastic or aesthetic surgery.
Adjustable bandages.

Mainat commercializes its products in over 40 countries through distributors.

Origin: Spain

Certifications:

ISO 13485:2016 and ISO 9001:2015 Certification delivered by Lloyd’s register

Mainat’s quality management system conforms to the ISO 9001 and ISO 13485 standards. Thanks to this certification Mainat can guarantee compliance with the strictest qualitative and regulatory standards for its products and services.

Oeko-Tex Standard 100

Oeko-Tex Standard 100 is the world leader in the field of consumer protection labels. It guarantees that the tested and certified textiles meet the regulatory thresholds for substances that may be harmful to human health (azo dyes, formaldehyde, heavy metals, etc.).

BAP MEDICAL

Bap Medical is a Dutch company which develops, produces and markets solutions for skin problems. The product range includes several brands covering different specialties:

Aftercare for burns.
Scar formation on deep wounds.
Aftercare following radiation therapy.
Skin complaints caused by eczema and other chronic skin disorders.
House dust mite allergy complaints.
Daily treatment of acute and chronic wound.

Bap Medical’s products are distributed in more than 40 countries around the world, particularly in Europe, the Middle East and Asia.

Origin: Netherlands

Certifications:

ISO 13485 certification delivered by KIWA / CERMET.

Bap Medical’s quality management system conforms to ISO 13485:2016 standards. Thanks to this certification Bap medical can guarantee compliance with the strictest qualitative and regulatory standards for its products and services.

CE marking

BAP MEDICAL’s products are Class 1 medical devices and meet the requirements of EEC directive 93/42 as well as its successive modifications.

M-TECHNOLOGIES

Founded in 2007, M-Technologie is a company that develops and produces medical and preventive devices made of silicon as well as innovative textiles. The products offered by the company include:

Silicone-based scar treatments: non-greasy and invisible gels, non-greasy gels, tinted with UV protection and silicone patches (thin and thick).
Compression garments: postoperative garments(liposuction) and garments for severe burns.
Preventive devices: belts for pregnant women.

M-Technologies has developed an international presence in 13 countries under different brands.

Origin : France

Certifications:

CE marking

M-Technologies’ products are Class 1 medical devices and meet the requirements of EEC directive 93/42 as well as its successive modifications.

ISO 13485:2016 certification

M-Technologies’ quality management system conforms ISO 13485:2016 standards. Thanks to this certification M-Technologies is able to guarantee compliance with the strictest qualitative and regulatory standards for its products and services.