Certifications
Documentation & Compliance
Certification and compliance records on file
I-TEC Health maintains certification, test and compliance records for its products and facilities, available for hospitals, distributors and procurement teams to review before progressing with an order.
Dates below reflect the documentation on file. Please confirm current validity with our team before relying on any certificate for a live order.
Product & Quality Certifications
ISO 13485:2016
Certificate No. 21273 · Euro Assessments & Certification Ltd
Medical Devices Quality Management System certification, covering the manufacturing, storage and distribution of disposable and surgical face masks. Initially registered 11 April 2020, issued 14 April 2020.
CE Declaration of Conformity
Certificate No. 21274 · Euro Assessments & Certification Ltd
Confirms our Disposable, Medical, Kids, KN95 FFP2 and Surgical Face Masks meet EU Medical Device (MDD/MDR) and PPE directive requirements, tested to EN 149:2001+A1:2009 and EN 14683:2019. EU representation held through A. Glynos & Sia E.E., Athens, Greece.
Bacterial Filtration Efficiency Test
Report No. 7191235951-CHM20-01-RC · TÜV SÜD PSB Singapore
Independent testing recorded an average bacterial filtration efficiency of 99.85% across three samples, using the ASTM F2101-19 standard method. Dated 17 April 2020.
KN95 Mask Performance Test
Report No. 21R000673 · GTTC, Guangzhou
Confirms our KN95 masks met EN 149:2001+A1:2009 requirements across practical performance, filter penetration, flammability, field of vision and breathing resistance. Issued 9 February 2021.
Good Distribution Practice
Certificate No. 000505 · Medical Device Authority, Malaysia
Covers importing, documentation and distribution of medical devices through our Malaysian distribution entity, One Gold Trading, based in Johor Bahru. Registration No. MASFMD 1010203.
Company & Regulatory Records
Singapore Company Registration
Steel Elite International Pte Ltd, the registered entity trading as I-TEC, incorporated in Singapore on 12 August 2016. Company No. 201622031D, confirmed in good standing with the Accounting and Corporate Regulatory Authority (ACRA).
Regulatory Import Compliance
Imports of surgical and medical masks notified to Singapore's Health Sciences Authority (HSA) under the applicable exemption order, as required for commercial supply.
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Let us know which product or facility documentation you need, and our team will confirm what's available.