ISO 13485
Ambito indicato: 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.
Apri anteprima ↗Documenti per acquirenti
Archivio documenti di prodotto
Consulta certificati del sistema qualità e documenti relativi a prodotti o materiali. I risultati riguardano solo campione, modello, metodo e data indicati; richiedi il file completo aggiornato per il tuo ordine.
Come verificare un documento
- Distingui certificato di sistema, test su campione, dichiarazione e notifica.
- Confronta prodotto, materiale, modello, metodo e data con ordine e mercato.
- Richiedi il documento completo aggiornato prima di usare qualunque dichiarazione.
Sistemi aziendali
ISO 9001
Ambito indicato: Export of Class I medical devices (nasal strips / mouth tape / body tape)
Management-system certificate; no finished-product approval is implied.
Apri anteprima ↗Documenti prodotti e materiali
RoHS
Ambito indicato: Mouth Tape, model HLKMT
Riferimento: BSTDGF526245241010381HC
Check the exact sample, tested standards and the original report; not a blanket production assessment.
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CE / EU notification
Ambito indicato: 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
Ambito indicato: 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
Ambito indicato: Medical adhesive sample, model ZTY-T060-T0616-T9800; Pony Testing report issued 31 Dec 2025
Riferimento: 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
Ambito indicato: 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
Ambito indicato: Face Tape (store card label)
Do not apply this report to nasal strips or mouth tape without model and sample matching.
Apri anteprima ↗SVHC (nasal strips)
Ambito indicato: Nasal Strips, model HLKNS, as named in the published sample report
Riferimento: 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.
Apri anteprima ↗Le immagini sono anteprime, non prove valide per tutti i prodotti. Verifica i dati in inglese nel documento originale completo.