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Certificates and documents

Documents issued to the manufacturer of our products, published here as a reference for our professional customers.

They are issued in the manufacturer's name, not YourSmile's. They are low-resolution copies and third parties' contact details have been hidden.

[Certificates and declaration of conformity in the name of YourSmile: pending from the manufacturer.]

Extract of the BSCI (amfori) social audit, 2020

BSCI (amfori): social audit

Issued by
SGS China (auditor)
Date
2020-10-15 / 2020-10-16

Extract of a labour audit of the factory. It is not a product certificate.

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FDA establishment registration confirmation page, 2021

FDA establishment registration (USA)

Issued by
FDA
Date
2021-01-13

Confirms the registration of the establishment. A registration is not an approval of the product.

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Letter from the Dutch CIBG on the notification of class I medical devices, 2020

Notification as class I medical devices (MDR 2017/745)

Issued by
CIBG, Dutch Ministry of Health
Date
2020-06-19

Letter confirming the notification of Mouth Tray, Teeth Whitening Gel, Teeth Whitening Kit and Teeth Whitening light, filed by the factory's EU representative. It is not a CE certificate.

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NQA ISO 13485:2016 certificate, expired in 2022

ISO 13485:2016: quality management system

Issued by
NQA (UKAS accredited)
Date
2019-12-12 / 2022-12-12

Certificate no. 47244. Scope: production and sale of tooth whitening instruments, gels and kits. It expired on 2022-12-12.

Expired on 2022-12-12

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