Frequently Asked Questions

Manufacturer – is an identification of manufacturer of the product. To meet a regulatory requirement for medical devices each packaging has to bear the name and address of manufacturer.

Date of Manufacture – is an identification the date on which a product was manufactured. This symbol should be adjacent to the date that the product was manufactured, expressed as four digits for the year, two digits for the month and two digits for the day, if applicable.

Batch Code or LOT Number – is an identification number assigned to a particular quantity or a material from single manufacture. Lot numbers can be found on the outside of packaging.
The lot number enables tracking manufacturer ingredients, labour and equipment records involved in the manufacturing of products. This can help manufacture to perform quality checks and expiration dates.
This number gives customer an identifier that they can use in contacting the manufacturer and researching the production of goods received.

Use by Date – is an identification that the device or product should not be used after the date accompanying the symbol. This symbol should be adjacent to the expiration date and might consist of four digits for the year, two digits for month and two digits for a day, if applicable.

European Conformity Mark – is an identification that the product conforms to European Medical Directive 93/42/EEC and meets applicable health, safety and environmental requirements.

European Authorised Representative – it is a legal requirement for manufacturer who places a device on European Union market under his own name to appoint a European Authorised Representative (EC Rep) that provides a point of contact between you (the non-European medical device manufacturer) the national Competent Authorities (Ministry of Health) and Notified Bodies.

Latex Free – is an identification that the product is not made from natural rubber latex or doesn’t contain any natural rubber. This information is essential for customers having an allergy reaction to latex.

Contain Latex – is an identification that the product is made of natural rubber latex or contain natural rubber. This information is essential for customers having an allergy reaction to latex.

Do Not Reuse – is an identification that the product can be “single use” or “use only once”.

Sterile – is an identification that the product is provided sterile and has been sterilised.

Sterile Using Irradiation – is an identification that the product is provided sterile and has been sterilised using irradiation.

Sterile Using Ethylene Oxide – is an identification that the product is provided sterile and has been sterilised using ethylene oxide.

Non Sterile – is an identification that the product that is normally provided sterile in the same or similar packaging has not been sterilized.

Single Sterile Barrier System – is an identification that the product has single barrier system.

Single Sterile Barrier with Protective Packaging Inside – is an identification that the product has single barrier system with protective packaging inside.

Do Not Resterilize – is an identification that the product is not to be resterilized.

Caution – essentially a cautionary symbol and should be used to highlight the fact that there are specific warnings or precautions associated with the product, which are not otherwise found on the label.

Recycling – is an identification that the product is capable of being recycled, not that the product has been recycled or will be accepted in all recycling collection systems.

Keep Dry – is an identification that the product should be kept away from rain and in dry conditions.

Keep Away from Sunlight – is an identification that the product should not be exposed to sunlight.

Do Not To Use if Package Is Damaged – is an identification that the product must not be used if the package holding the product is damaged. Damaged package can disintegrate of the contents or the continuity of their special condition (such as sterility) is compromised if the package bearing the symbol is damaged or prematurely opened.

Consult Instructions for Use – is an identification on product or product packaging that relevant information for use of the product is available in printed paper form.

Temperature Limit – is an identification that the product has the maximum and minimum temperature limits at which the item should be stored, transported or used. The temperature values may be indicated adjacent to the symbol with the minimum temperature at the lower left and the maximum temperature at the upper right.