Certifications
Documentation & Compliance
Certification and compliance records on file
I-TEC 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. Our ISO 13485 scope covers design and development as well as production, so the products carrying our name were developed under the same certified system that makes them.
For the current status of any certificate ahead of a live order, contact our team directly.
Product & Quality Certifications
ISO 13485:2016
Certificate No. Q8 113766 0001 & Q5 113766 0002 · TÜV SÜD Product Service GmbH (DAkkS-accredited)
Medical Devices Quality Management System certification, covering storage and distribution of non-active, non-implantable and in-vitro diagnostic medical devices, and design, development, production, distribution and storage of medical face masks. Issued 5–6 July 2022.
CE Declaration of Conformity
Module B Cert. FI20/967157 & Module C2 Cert. CN20/42530 · SGS Fimko Oy
Confirms our Medical Kids Mask, Surgical Face Mask, Disposable Face Mask, Medical Face Mask, FFP2 Particle Filtering Half Mask, KN95 FFP2 Medical Mask, KF94 and KF99 respirator masks meet EU Medical Device (MDD/MDR) and PPE directive requirements, tested to EN 149:2001+A1:2009 and EN 14683:2019. Dated 30 July 2021.
ISO 13485:2016
Certificate No. 21273 · UIC EA9488 · Euro Assessments & Certification Ltd · Issued 14/04/2020, expiry 13/04/2023
Medical Devices Quality Management System certification issued to Steel Elite International Pte Ltd, covering the manufacturing, storage and distribution of disposable and surgical face masks.
CE Certificate of Compliance
Certificate No. 21274 · Euro Assessments & Certification Ltd · Issued 05/06/2020, expiry 04/06/2023
Compliance certificate covering the Disposable Face Mask, Medical Face Mask, Medical Kids Mask, KN95 FFP2 Medical Mask and Surgical Face Mask ranges, assessed against EN 149:2001+A1:2009 and EN 14683:2019 under the MDD, MDR and PPE directives.
EU Type-Examination Certificate
Certificate No. 0598/PPE/21/2305 · SGS Fimko Ltd, Notified Body 0598
Covers our ITM-KN08 particle filtering half mask (FFP2 NR classification) under Regulation (EU) 2016/425, tested to EN 149:2001+A1:2009. Issued 8 September 2021, valid until 8 September 2026.
Manufacturing Certification (Module C2)
Certificate No. CN20/42530 · SGS Fimko Oy
Certifies our manufacture of the I-TEC ITM-KN08 particle filtering half mask under Regulation (EU) 2016/425. Certified since 18 July 2021, subject to satisfactory surveillance audits.
Multi-Site Manufacturing Certification (Module D)
Certificate CN21/42708 · SGS Fimko Oy
Covers manufacture of FFP2 protective respirators under Regulation (EU) 2016/425, across our Singapore site and an additional partner facility, Guangzhou Aikanger Labor Insurance Products Co., Ltd. Certified since 31 October 2021.
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.
Regulatory Registration
Manufacturer's Dealer Licence (Class A)
Licence No. ES0501690 · Singapore Health Sciences Authority (HSA)
Our licence to manufacture Class A medical devices in Singapore, approved for our production site at 59 Ubi Avenue 1, Bizlink Centre. Approved 3 December 2021.
Registered Medical Device: Face Mask (Class A)
Registration No. GA8463021-53107 · Singapore HSA
Covers five registered I-TEC face mask products — Disposable, Medical, Medical Kids and two Surgical Mask variants — each with its own listed device identifier.
Certificate of Free Sale
Notarised, Republic of Singapore
Confirms six I-TEC mask products as manufactured by Steel Elite International Pte Ltd, saleable and distributable in Singapore and overseas. Notarised 7 January 2021.
Company & Regulatory Records
Singapore Company Registration
ACRA · Company No. 201622031D
Steel Elite International Pte Ltd, the registered entity trading as I-TEC, incorporated in Singapore on 12 August 2016, confirmed in good standing with the Accounting and Corporate Regulatory Authority (ACRA).
Good Distribution Practice (Malaysia)
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.
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Let us know which product or facility documentation you need, and our team will confirm what's available.