Regulatory Documents
Medical devices are regulated by national authorities and international rules. All Orfit products comply with these rules and regulations and are, as 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 regulation. 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 (Regulation (EU) 2017/745).
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
Physical Rehabilitation - accessories
Prosthetics & Orthotics - Orfitrans
Radiation Oncology - Thermoplastic materials
- Raycast® Uon and Duon Masks
- Raycast® High Precision Thermoplastic Bolus Material
- Raycast® High Precision Masks for Extracranial Immobilization
- Raycast® High Precision Efficast® Thermoplastic Material for Patient Immobilization - Sheet Material
- Raycast® High Precision Efficast® Masks, Nanor Masks and Hybrid Masks with Nanor for other Hardware
- Raycast® High Precision Efficast® Masks, Nanor Masks and Hybrid Masks with Nanor for Head, Neck and Shoulders
Radiation Oncology - Hardware & Accessories
- Aerial® Couchtop for Proton Therapy
- Vacuum Pumps
- Vacuum Bag Cushions
- Thermofit
- The AIO Solution
- SRS Fix and Bite Fix
- SBRT
- Sagittilt™ Prone Breast Solution
- Raycast® High Precision Positioning Lung Board Solution
- Raycast® High Precision Positioning aids for arms and shoulders
- Raycast® High Precision Accessories Head Supports regular density
- Raycast® High Precision Accessories Head Supports regular density for push-pin hardware
- Raycast® High Precision Accessories Head Supports regular density extra soft for Cyberknife (for other hardware)
- Raycast® High Precision Accessories Head Supports Low Density
- Raycast® High Precision Accessories Head Supports Low Density for push-pin hardware
- Raycast® High Precision Accessories Blocks and Wedges MRI compatible
- Raycast® High Precision Accessories Blocks and Wedges Low Density
- Raycast® High Precision Accessories Blocks and Wedges High Density
- Raycast® High Precision – Patient Support Cushions
- Raycast® High Precision – Orfit Extremities Solution
- Raycast®-High-Precision-Base-Plate-To-Couch-Fixation-Devices
- Raycast® High Precision Base Plates
- Raycast® High Precision Accessories Head Supports Prone Head Supports
- Raycast® - Uon and Duon Base Plate
- MRI-S Solution
- MRI-S Solution for Head, Neck and Shoulders
- MRI-P Solution for Head and Neck
- MRI-G Solution for Head and Neck
- Moldcare
- MammoRX®
- Integra™
- HP PRO Solution
- Dry Heat Convection Oven
- Moldcare
- Vacuum Pumps
- Vacuum Bag Cushions