How to review a file
- Identify the document type: a quality-system certificate, sample test, declaration or notification serves a different purpose.
- Match the product name or material, model, tested method and report date to your intended order and market.
- Ask for the full current file and confirm applicability before using any claim or artwork.
Company systems

ISO 13485
Listed scope: Sales of Class I medical machinery (semi-finished products of disposable medical adhesive paper for external fixation)
Company quality-management system only; not manufacturing or product certification.
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ISO 9001
Listed scope: Export of Class I medical devices (nasal strips / mouth tape / body tape)
Management-system certificate; no finished-product approval is implied.
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RoHS
Listed scope: Mouth Tape, model HLKMT
Reference: BSTDGF526245241010381HC
Check the exact sample, tested standards and the original report; not a blanket production assessment.
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CE / EU notification
Listed scope: Nasal strips, model HLKNS1, in the published EU representative notification
A notification is not EU authority approval or a third-party CE certificate for all models. Request the matching declaration and technical file.
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MSDS
Listed scope: Mouth Tape; Nasal Strips (store card labels)
This is a watermarked, partial preview marked as a sample; request the complete current sheet. An MSDS is not a finished-product efficacy test.
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ISO 10993-10 sensitization test
Listed scope: Medical adhesive sample, model ZTY-T060-T0616-T9800; Pony Testing report issued 31 Dec 2025
Reference: GTLA2NDA3173585L8
Full report reviewed: under the specified ISO 10993-10:2021 test conditions, this sample showed no skin sensitization reaction. The report does not identify every finished nasal-strip or mouth-tape SKU; request a model-to-material match before applying this result to a selected finished product.
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PFAS test report
Listed scope: Medical adhesive patch sample
The public cover does not show test results. Request the full report before making a PFAS-free claim.
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REACH
Listed scope: Face Tape (store card label)
Do not apply this report to nasal strips or mouth tape without model and sample matching.
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SVHC (nasal strips)
Listed scope: Nasal Strips, model HLKNS, as named in the published sample report
Reference: KTi250922R1936
The visible summary applies to the submitted sample and substances tested. Request the complete current report for your selected model; it does not cover all products.
Open document preview ↗Images are previews for reference, not proof that every HLK product has the same result or regulatory status. The English document descriptions reflect the file or store listing and should be checked against the complete original.