Regulatory Documents
Medical devices are regulated by national authorities and international rules. All Orfit products comply with these rules and regulations and are such freely available all over the world.

FDA stands for the U.S. Food and Drug Administration, an agency of the United States Department of Health and Human services. The FDA legislation protects the public health through the regulation and supervision of food and medical products. Our products are in compliance with the Federal Food, Drug and Cosmetic Act (FD&C Act) Code of Federal Regulations Title 21 part 808/812/820.
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REACH is the European Community Regulation for chemicals and their safe use. REACH is the abbreviation for Registration, Evaluation, Authorization and restriction of Chemical substances. The purpose is to protect human health and the environment by a better and earlier identification of the intrinsic properties of chemical substances. According to this law, substances of very high concern may no longer be used in products.
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Products that are brought onto the European market must meet the essential requirements of the European product CE marking certification directives. With this mark, we declare that all products made by Orfit Industries comply with the essential requirements of the European health, safety and environmental protection legislation (Directive 93/42/EC).
Search and download the Declaration of Conformity here.
Search and download the Declaration of Conformity here.

ISO is the International Organization for Standardization. ISO facilitates and supports international trade by developing standards. These standards are recognized and respected worldwide. Orfit Industries is certified for the Quality Management System ISO 13485 (2016).
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Physical Rehabilitation - products
- Aquafit™ NS
- Allfit
- Soft Fit® NS
- Orfizip®
- Orfizip® NS and Orfizip® Black NS
- Orfit® Eco NS
- Orfizip® Light NS
- Orfit® Eco
- Orfit® Flex NS
- Orfit® NS
- Orfit® Strips
- Orfit® Eco Black NS
- Orfit® Ease
- Orfit® Colors NS
- Orfit® Colors NS Precuts
- Orfit® Classic
- Orfit® Classic Hand Splints
- Orfilight®
- Orfilight® Black NS
- Orfilight® Atomic Blue NS
- Colorfit® NS
- Dynasyst
- Orfibrace™
- Orficast™ Thermoplastic Tape Black
- Orficast™ Thermoplastic Tape
- Orfitrans™ Medium Soft
Physical Rehabilitation - accessories
Prosthetics & Orthotics - Orfitrans
Radiation Oncology - Thermoplastic materials
- Raycast® High Precision Efficast masks, Nanor masks and hybrid masks with Nanor for patient immobilisation for head, neck and shoulders
- Raycast® High Precision Efficast masks, Nanor masks and hybrid masks with Nanor for head, neck and shoulder fixation for other hardware
- Raycast® High Precision Efficast masks for head, neck and shoulder fixation for other hardware without profiles
- Raycast® High Precision Efficast Thermoplastic sheet materials
- Raycast® High Precision Thermoplastic bolus material
- Raycast® High Precision masks for extracranial immobilization
- Thermofit
- Raycast® Uon and Duon masks for head and neck
- Raycast® High Precision interfaces and adapters
- Raycast® High Precision Nanor thermoplastic material for patient immobilisation masks for head, neck and shoulders
- Raycast® High Precision Nanor thermoplastic material for patient immobilisation masks for head, neck and shoulders for push pin hardware
Radiation Oncology - Hardware & Accessories
- Raycast® High Precision Orfit extremities solution
- Raycast® High Precision patient support cushions
- Raycast® High Precision pelvic and abdomen patient immobilization system
- Raycast® High Precision positioning aids for arms and shoulders
- Raycast® High Precision prone head supports
- Raycast® High Precision regular density head supports for push pin hardware
- Raycast® Uon Duon base plates
- Sagittilt™ prone breast solution
- SBRT
- The AIO Solution knee feet cushions indexed
- The AIO Solution
- Vacuum bag cushions
- Vacuum Pumps
- Integra
- Lungboard
- MammoRX® carbon fibre breast immobilization systems
- MRI solution for GE MRI G solution for head neck shoulders
- MRI solution for Philips MRI P solution for head neck and shoulders
- Proton immobilization system (HP PRO Solution)
- Raycast® High Precision interfaces and adapters
- Raycast® High Precision head support low density
- Raycast® High Precision base plates
- Raycast® High Precision base plate to couch fixation devices
- Raycast® High Precision accessories low density head supports for push-pin hardware
- Raycast® High Precision accessories head supports regular density
- Raycast® High Precision accessories head supports regular density extra soft for multi-point base plates with push-pins
- Raycast® High Precision accessories head supports - regular density extra soft
- Raycast® High Precision accessories block and wedges low density
- Raycast® High Precision accessories block and wedges high density
- Raycast® High Precision accessories MRI compatible block and wedges
- Raycast® Duon masks for head and neck
- Thermofit
- Digital Dry Heat Convection Oven