e-Symbol Glossary - Hartalega

SYMBOL GLOSSARY DEFINITIONS

SYMBOL TITLE	DESCRIPTION	STANDARD REFERENCE	STANDARD TITLE
Manufacturer	Indicates the medical device manufacturer	ISO 15223-1: 2021 Reference no. 5.1.1	Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
Authorized Representative in the European Community/ European Union	Indicates the authorized representative in the European Community / European Union	ISO 15223-1: 2021 Reference no. 5.1.2	Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
Authorized Representative in Switzerland	Indicates the authorized representative in Switzerland	ISO 20417 Reference no. 6.1.2 (d)	Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
Importer	Indicates the entity importing the medical device into the locale	ISO 15223-1: 2021 Reference no. 5.1.8	Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
Distributor	Indicates the entity distributing the medical device into the locale	ISO 15223-1: 2021 Reference no. 5.1.9	Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
Country of Manufacture	To identify the country of manufacture of products	ISO 15223-1: 2021 Reference no. 5.1.11	Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
Do Not Re-use	Indicates a medical device that is intended for one single use only NOTE: Synonyms for “Do not reuse” are “single use” and “use only once”.	ISO 15223-1:2021 Reference no. 5.4.2	Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
Date of Manufacture	Indicates the date when the medical device was manufactured	ISO 15223-1: 2021 Reference no. 5.1.3	Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
Use-by Date	Indicates the date after which the medical device is not to be used	ISO 15223-1: 2021 Reference no. 5.1.4	Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
Batch Code	Indicates the manufacturer's batch code so that the batch or lot can be identified. NOTE: Synonyms for “batch code” are “lot number”, “lot code” and “batch number”.	ISO 15223-1: 2021 Reference no. 5.1.5	Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
Unique Device Identifier	Indicates a carrier that contains unique device identifier information	ISO15223-1: 2021 Reference no. 5.7.10	Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
Medical Device	Indicates the item is a medical device	ISO 15223- 1:2021 Reference no. 5.7.7	Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
Catalogue number	Indicates the manufacturer's catalog number so that the medical device can be identified	ISO 15223-1: 2021 Reference no. 5.1.6	Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
Model Number	Indicates the model number or type number of a product	ISO 15223-1: 2021 Reference no. 5.1.10	Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
Serial Number	Indicates the manufacturer's serial number so that a specific medical device can be identified	ISO 15223-1: 2021 Reference no. 5.1.7	Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
Consult Instructions for Use or Consult Electronic Instructions for Use	Indicates the need for the user to consult the instructions for use	ISO 15223-1:2021 Reference no. A.16	Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
Consult Instructions for Use or Consult Electronic Instructions for Use	Indicates the need for the user to consult the instructions for use	ISO 15223-1:2021 Reference no. 5.4.3	Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
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 a medical device	ISO 15223-1: 2021 Reference no. 5.4.5	Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
Not Made with or Absence of Natural Rubber Latex	Indicates the absence of dry natural rubber or natural rubber latex as a material of construction within the medical device or the packaging of a medical device	ISO 15223-1: 2021 Reference no. Annex B (b.2)	Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
Do Not Use if Package is Damaged and Consult Instructions for Use	Indicates 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	ISO 15223-1: 2021 Reference no. 5.2.8	Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
Sterile	Indicates a medical device that has been subjected to a sterilization process	ISO 15223-1: 2021 Reference no. 5.2.1	Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
Sterilized Using Irradiation	Indicates a medical device that has been sterilized using irradiation	ISO 15223-1: 2021 Reference 5.2.4	Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
Non-Sterile	Indicates a medical device that has not been subjected to a sterilization process	ISO 15223-1: 2021 Reference no. 5.2.7	Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
Single Sterile Barrier System with Protective Packaging Inside	Indicates a single sterile barrier system with protective packaging inside	ISO 15223-1: 2021 Reference no. 5.2.13	Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
Single Sterile Barrier System with Protective Packaging Outside	Indicates a single sterile barrier system with protective packaging outside	ISO 15223-1: 2021 Reference no. 5.2.14	Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
Keep Away from Sunlight	Indicates a medical device that needs protection from light sources	ISO 15223-1: 2021 Reference no. 5.3.2	Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
Keep Dry	Indicates a medical device that needs protection from moisture	ISO 15223-1: 2021 Reference no. 5.3.4	Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
Temperature Limit	Indicates the temperature limits to which the medical device can be safely exposed	ISO 15223-1: 2021 Reference no. 5.3.7	Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
CE Marking	CE marking of conformity means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation legislation providing for its affixing	Regulation (EU) 2017/745 Reference no. Annex V	REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
UKCA Marking	UKCA marking of conformity means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements for products sold within Great Britain	The Medical Devices Regulations 2002	The Medical Devices Regulations 2002
Swiss MD Marking	Swiss MD marking of conformity means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements for products sold within Switzerland	Medical Devices Ordinance (MedDO) Reference no. Annex 5	Medical Devices Ordinance (MedDO)

Recruitment PDPA Notice

By engaging or communicating with Hartalega Holdings Berhad (“Company”) for the purposes of applying for a position with the Company, or entering into an employment agreement, contract of service or contract for service between you and the Company, you consent to the processing of your personal data identified below and you confirm that all information is accurate and complete, and that none of it is misleading or out of date.

The data may include any personal data, sensitive personal data and/or information about you which were provided to the Company, including but not limited to the following:

name, age, identification number and/or passport number, nationality, race, date and place of birth, gender, ethnicity, marital status, residential address, home and office telephone number, mobile contact number, personal email address, bank account number, academic records, professional qualifications, EPF number, SOCSO number, income tax number, employment history and the name and contact details of your next-of-kin or any other information necessary to process your personal data for job application purposes.

(collectively known as “Personal Data”)

Apart from the Personal Data collected above, the Company may also obtain and process data including but not limited to:

any medical conditions and medications taken by you (where applicable), political opinions, religious beliefs, information relating to your spouse, child and/or other family members or commission or alleged commission by you of any offence (“Sensitive Personal Data”).

The Company may have obtained your Personal Data or Sensitive Personal Data directly from you or through verification for third party sources such as job listing platforms, human capital management platforms, credit reporting agencies, the Insolvency Department and/or other local authorities.
We will collect and use your Personal Data and/or Sensitive Personal Data for any of the following purposes:

assessing your skills, qualifications and suitability for a role in the Company;
processing employment application, including conducting background checks, pre-employment verification of information provided by you;
determining and payment of salaries, incentives, bonuses, employment stock options, group medical benefits, and other benefits;
maintaining records in relation to the Company’s recruitment process;
monitoring compliance with our internal rules and policies;
complying with the compliance and disclosure requirements of all governmental and/or quasi-governmental departments and/or agencies, regulatory and/or statutory bodies (e.g. Inland Revenue Board, the Employee’s Provident Fund Board, the Social Security Organisation, Bank Negara Malaysia);
reserving our rights under employment law or any other applicable laws to enforce or defend our rights under the law in relation to matters including but not limited to any disciplinary action or actions relating to the termination of employment; and
any purposes relating thereto.

(collectively known as “Purposes”)

It is voluntary for you to supply your Personal Data and/or Sensitive Personal Data to us, however, should you refuse, we may not be able to process your application for employment successfully.
The Company may disclose your Personal Data and/or Sensitive Personal Data to third parties such as (a) service providers relating to IT, records management storage, banks, insurance and professional advisors; and (b) governmental departments and/or regulatory and/or statutory bodies where required by law.

Where the Company’s service providers are located outside Malaysia, your Personal Data and/or Sensitive Personal Data may be transferred to, stored, used and processed outside Malaysia. You consent to the transfer and use of your Personal Data and/or Sensitive Personal Data outside Malaysia.

Your Personal Data and/or Sensitive Personal Data shall be retained by the Company for as long as it is necessary to fulfil the purpose for which it was collected or as required or permitted by applicable laws.

The Company is committed to safeguarding your Personal Data and/or Sensitive Personal Data and ensuring that it is stored securely. You are entitled to request access to and/or make correction to your Personal Data and/or Sensitive Personal Data, or to refuse or limit the processing of your Personal Data and/or Sensitive Personal Data by writing to the following:

Data Protection Officer
Hartalega NGC Sdn Bhd
No. 1, Persiaran Tanjung,
Kawasan Perindustrian Tanjung,
43900 Sepang, Selangor
Email: [human.resource@hartalega.com.my]
Phone: [03-8707 3000]

Notwithstanding the withdrawal of your consent, the Company may still proceed to process your Personal Data and/or Sensitive Personal Data in circumstances recognised and permitted by law. The Company also has the right to refuse or deny such requests to access and/or correct your Personal Data and/or Sensitive Personal Data under applicable laws.

The Company may also collect Personal Data of your professional or personal referees, including your referee’s name, residential address, occupation, and contact number. If you provide your referees’ Personal Data, you warrant and represent that you have informed your referee that you will be providing their Personal Data to the Company, and that you have obtained your referees’ consent for the Company to process their Personal Data.

AGREE

Recruitment PDPA Notice

The data may include any personal data, sensitive personal data and/or information about you which were provided to the Company, including but not limited to the following:

name, age, identification number and/or passport number, nationality, race, date and place of birth, gender, ethnicity, marital status, residential address, home and office telephone number, mobile contact number, personal email address, bank account number, academic records, professional qualifications, EPF number, SOCSO number, income tax number, employment history and the name and contact details of your next-of-kin or any other information necessary to process your personal data for job application purposes.

(collectively known as “Personal Data”)

Apart from the Personal Data collected above, the Company may also obtain and process data including but not limited to:

any medical conditions and medications taken by you (where applicable), political opinions, religious beliefs, information relating to your spouse, child and/or other family members or commission or alleged commission by you of any offence (“Sensitive Personal Data”).

assessing your skills, qualifications and suitability for a role in the Company;
processing employment application, including conducting background checks, pre-employment verification of information provided by you;
determining and payment of salaries, incentives, bonuses, employment stock options, group medical benefits, and other benefits;
maintaining records in relation to the Company’s recruitment process;
monitoring compliance with our internal rules and policies;
complying with the compliance and disclosure requirements of all governmental and/or quasi-governmental departments and/or agencies, regulatory and/or statutory bodies (e.g. Inland Revenue Board, the Employee’s Provident Fund Board, the Social Security Organisation, Bank Negara Malaysia);
reserving our rights under employment law or any other applicable laws to enforce or defend our rights under the law in relation to matters including but not limited to any disciplinary action or actions relating to the termination of employment; and
any purposes relating thereto.

(collectively known as “Purposes”)

Data Protection Officer
Hartalega NGC Sdn Bhd
No. 1, Persiaran Tanjung,
Kawasan Perindustrian Tanjung,
43900 Sepang, Selangor
Email: [human.resource@hartalega.com.my]
Phone: [03-8707 3000]

AGREE

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SYMBOL GLOSSARY DEFINITIONS

Recruitment PDPA Notice

Recruitment PDPA Notice

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