Библиотека документов на продукцию

ISO 13485

Указанная область: 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.

ISO 9001

Указанная область: Export of Class I medical devices (nasal strips / mouth tape / body tape)

Management-system certificate; no finished-product approval is implied.

RoHS

Указанная область: Mouth Tape, model HLKMT

Номер: BSTDGF526245241010381HC

Check the exact sample, tested standards and the original report; not a blanket production assessment.

CE / EU notification

Указанная область: 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.

MSDS

Указанная область: 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.

ISO 10993-10 sensitization test

Указанная область: Medical adhesive sample, model ZTY-T060-T0616-T9800; Pony Testing report issued 31 Dec 2025

Номер: 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.

PFAS test report

Указанная область: Medical adhesive patch sample

The public cover does not show test results. Request the full report before making a PFAS-free claim.

REACH

Указанная область: Face Tape (store card label)

Do not apply this report to nasal strips or mouth tape without model and sample matching.

SVHC (nasal strips)

Указанная область: Nasal Strips, model HLKNS, as named in the published sample report

Номер: 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.