SYMBOLS EXPLAINED

The EU MDR is a set of regulations released in 2017 by the European Union to ensure high safety and quality standards for medical devices in member countries. It replaces the previous Medical Device Directive (MDD) and aims to improve health and safety while supporting innovation. Companies have a transition period until May 2021 to comply with the new regulations. The EU MDR introduces changes, including a unique device identification system and requirements for technical documentation. It covers various classes of medical devices based on risk levels. The goal is to enhance the safety and performance of medical devices and improve overall healthcare safety.

At Tytex we are dedicated to providing optimal healthcare solutions. As part of this commitment, Tytex is actively and continuously working on implementing the findings of the EU MDR legislation framework as well as other relevant legislation. By adhering to the regulations and requirements set forth in the EU MDR and other legislation, we at Tytex aims to ensure that our medical devices meet the highest standards of safety and quality.

Implementing the EU MDR framework allows Tytex to stay up to date with the latest industry standards and best practices. By doing so, we can offer innovative

and reliable healthcare solutions to all customers while prioritizing patient safety and well-being.

By proactively embracing the EU MDR legislation, Tytex demonstrates our commitment to continuously improving our products and processes. This also includes updating technical documentation, complying with the unique device identification system, and implementing a robust Quality Management System.

Through our diligent work with implementing the EU MDR framework, we ensure that all healthcare solutions are in line with the regulatory requirements and contribute to the overall goal of enhancing the safety and performance of medical devices. By doing so, we provide healthcare professionals and patients with trusted and reliable products that meet the highest quality standards.

Below you can learn more about the symbols we employ for various material. Should you have any questions please let us know or contact our Compliance Manager at [email protected] or by phone on +45 5154 7471.

NAME OF SYMBOL	SYMBOL	EXPLANATION OF SYMBOL
Manufacturer		Who is the manufacturer
Country of manufacture		Which country is the product manufactured in
Date of manufacture		When is the product manufactured
Importer		Who is the importer of the product
Distributor		Who is the distributor of the product
Use by date		Expiry date
Medical Device		To signify that the contents of the package are approved under The Medical Devices Regulation 2017/745/EU
EU Authorized Representative Role		EU Authorized Representative employed
Swiss authorized representative		The symbol description is as follows: «Indicates the authorized representative in Switzerland»
Batch code		Symbol preceding the unique alphanumeric code assigned to a specific set of products, enabling their identification and traceability based on shared production characteristics
Catalogue number		Symbol preceding a unique identifier assigned to any transaction
Serial number		Symbol preceding the identification number showing the position of a printed or manufactured item in a series
Unique device identifier		Identifier bar code or data carrier containing the required UDI information
Quantity		Symbol which together with a number shows amount of pieces in a specific packaging
Trash box or litter bin or rubbish bin		To designate a container specifically designed for the collection of waste materials, including trash, litter, or discarded rubbish
Keep away from sunlight		To signal that the transportation packaging should be shielded from direct sunlight exposure
Keep away from rain		To communicate the requirement for the transportation package to be safeguarded from rain and stored in dry conditions
Protect from heat and radioactive sources		To signify that the contents of the package are susceptible to degradation or complete unusability due to exposure to heat or ionizing radiation, emphasizing the necessity of safeguarding them against these factors
Do not use if package is damaged		To signify that the device should not be utilized in the event of any damage to the packaging containing the device, such as in the case of medical device packaging
Operator's manual; operating instructions		To designate the designated storage location for the operator's manual or to indicate information pertaining to the operating instructions. It serves as a reminder that the operating instructions should be consulted when operating the device or controlling it in proximity to the symbol's placement
Electronic operator's manual; operating instructions		To designate the designated electronic storage location for the operator's manual or to indicate information pertaining to the operating instructions. It serves as a reminder that the operating instructions should be consulted when operating the device or controlling it in proximity to the symbol's placement
Patient information website		To provide a reference to a website where patients can access supplementary information regarding the medical product
Single patient multiple use		To signify that the medical device is intended for multiple use on a single patient, allowing for its application in multiple procedures
Do not re-use		To signify that the item is intended for single use only and must not be reused or utilized more than once, as seen on packages of medical disposables
Caution		To highlight the importance of exercising caution while operating the device or control in close proximity to the symbol's placement. It serves as a reminder that the current situation demands operator awareness or action to prevent undesirable consequences. On the health app quality label: to indicate that the health app necessitates approval from a healthcare professional prior to use
Contains or presence of		On medical devices: to signify the presence of the identified product or substance within the equipment
Translation		To indicate that the original medical device information has been translated, providing supplementary or replacement information to the original content
Repackaging		To identify that a modification to the original medical device packaging configuration has occurred
Wash by hand		To signify that the textile article is exclusively suitable for hand washing and should not be cleaned by any other method
Wash at 40 degrees		To indicate the the garment is to be washed at 40 degrees Celsius
Wash at 60 degrees		To indicate the the garment is to be washed at 60 degrees Celsius
Do not bleach		To signify that the textile article should not be subjected to any form of bleaching
Tumble drying, maximum 60 Celsius		To signify that the textile article is suitable for tumble drying but only at low temperature settings, with a maximum exhaust temperature of 60 degrees Celsius
Do not dry clean		To signify that the textile article should not be subjected to dry cleaning
Latex free		To signify that the textile article is free from Latex