Documentación para compradores

Biblioteca de documentos de producto

Consulte certificados de sistemas de calidad e informes de productos o materiales. Los resultados se limitan a la muestra, el modelo, el método y la fecha indicados; solicite el archivo vigente completo para su pedido.

Cómo comprobar un documento

  1. Distinga entre certificado de sistema, ensayo de muestra, declaración y notificación.
  2. Compruebe producto, material, modelo, método y fecha frente a su pedido y mercado.
  3. Pida el documento vigente completo antes de utilizar una afirmación comercial.

Sistemas de la empresa

ISO 13485

Alcance indicado: 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

Alcance indicado: 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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Informes de productos y materiales

RoHS

Alcance indicado: Mouth Tape, model HLKMT

Referencia: BSTDGF526245241010381HC

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

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CE / EU notification

Alcance indicado: 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

Alcance indicado: 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

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

Referencia: 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

Alcance indicado: 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

Alcance indicado: 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)

Alcance indicado: Nasal Strips, model HLKNS, as named in the published sample report

Referencia: 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.

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Las imágenes son vistas previas, no pruebas para todos los productos. Verifique las descripciones del archivo original en inglés.

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