Manufacturer
Indicates the medical device manufacturer, as defined in EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC. SS-EN ISO 15223-1:2021.
Distributor
Indicates the entity distributing the medical device into the locale.
Importer
Indicates the entity importing the medical device into the locale.
Authorized representative in the European Community/European Union
Indicates the authorized representative in the European Community/ European Union.
Authorised representative for Switzerland
Indicates the authorised representative in Switzerland.
Authorised representative for UK
Indicates the authorized representative in the UK.
CE-mark
Indicates manufacturer declaration that the product complies with the essential/ general safety & performance requirements of the relevant European medical device, health, safety and environmental protection legislations.
European Medical Devices Directive 93/42/EEC of 14 June 1993 (as amended by Directive 2007/47/EC). European Medical Device Regulation 2017/745.
CE-mark with notified body number
Indicates manufacturer declaration that the product complies with the essential/ general safety & performance requirements of the relevant European medical device, health, safety and environmental protection legislations.
European Medical Devices Directive 93/42/EEC of 14 June 1993 (as amended by Directive 2007/47/EC). European Medical Device Regulation 2017/745.
Medical device
Indicates that the device is a medical device as defined in MDR 2017/745.
Date of manufacture
Indicates the date when the medical device was manufactured.
Use-by date
Indicates the date after which the medical device is not to be used.
Batch code
Indicates the manufacturer’s batch code so that the batch or lot can be identified. SS-EN ISO 15223-1:2021.
Catalogue number
Indicates the manufacturer’s catalogue number so that the medical device can be identified.
Unique device identifier
Indicates a carrier that contains uniques device identifier information.
Single use
Indicates a medical device that is intended for one single use only.
Non-sterile
Indicates a medical device that has not been subjected to a sterilization process.
Sterile
Indicates a medical device that has been subjected to a sterilization process.
Sterilized using ethylene oxide
Indicates a medical device that has been sterilized using ethylene oxide.
Sterilized using irradiation
Indicates a medical device that has been sterilized using irradiation.
Do not resterilize
Indicates a medical device that is not to be re-sterilized.
Single sterile barrier system
Indicates a single sterile barrier system.
Single sterile barrier system with protective packaging inside
Indicates a single sterile barrier system with protective packaging inside.
Caution
Indicates that caution is necessary when operating the device or control close to where the symbol is placed, or that the current situation needs operator awareness or operator action in order to avoid undesirable consequences.
Consult instruction for use
Indicates the need for the user to consult the instructions for use.
Contains or presence of natural rubber latex
Indicates the presence of dry natural rubber or natural rubber latex as a material of construction within the medical device or the packaging of medical device.
Fluid path
Indicates the presence of a fluid path.
One-way valve
Indicates a medical device with a valve that allows flow in only one direction.
Non-pyrogenic
Indicated a medical device that is non-pyrogenic.
Drops per millilitre
Indicates the number of drops per millilitre.
Liquid filter with pore size
Indicates an infusion or transfusion system of the medical device that contains a filter of a particular nominal pore size.
Do not use if package is damaged and consult instructions for use
Indicates that a medical device that should not be used if the package has been damaged or opened and that the user should consult the instructions for use for additional information.
Keep away from sunlight
Indicates a medical device that needs protection from light sources.
Keep dry
Indicates a medical device that needs to be protected from moisture.
Temperature limit
Indicates the temperature limits to which the medical device can be safely exposed.
*The temperature shown in the symbol is assested by OMP QE team.
Upper limit of temperature
Indicates the temperature limits to which the medical device can be safely exposed.
*The temperature shown in the symbol is assested by the QE team..






























