Quality & Certifications

1. Our Quality Commitment

Capilux Medical is committed to supplying medical products and medical devices with appropriate attention to product quality, regulatory documentation, traceability and applicable European conformity requirements.

Our quality approach is based on maintaining and reviewing relevant technical, regulatory and commercial documentation applicable to the products we supply.

2. CE Conformity

Where required by applicable European legislation, relevant medical devices supplied by Capilux Medical are supported by applicable CE conformity documentation.

CE marking indicates that the relevant product has been assessed under the applicable European conformity framework before being placed on the market, where CE marking is legally required.

CE status is product-specific. The presence of CE documentation for one product does not automatically apply to all products offered by Capilux Medical.

3. Regulation (EU) 2017/745 — Medical Device Regulation

Capilux Medical maintains documentation relating to the requirements of Regulation (EU) 2017/745 on medical devices (MDR), where applicable to the relevant products and economic operator activities.

MDR-related documentation may include, depending on the product and role within the supply chain:

• Conformity documentation
• Declarations of Conformity
• Product identification information
• Manufacturer and economic operator information
• Labelling and Instructions for Use
• Traceability records
• Technical and regulatory documentation where applicable

4. EUDAMED

Capilux Medical maintains applicable EUDAMED-related registration and documentation supporting activities within the European medical device regulatory framework.

EUDAMED is the European database established to support transparency, traceability and regulatory oversight of medical devices and relevant economic operators within the European Union.

Registration information and supporting documentation may be provided to competent business partners or authorities where appropriate and legally permitted.

5. ISO Certification

Capilux Medical maintains ISO certification documentation relevant to its quality and operational framework.

Specific ISO standard numbers, certification scope, certificate numbers, issuing certification body and validity periods may be presented separately where applicable.

ISO certification claims are made only within the scope covered by valid supporting certification documentation.

6. Regulatory & Quality Documentation

Depending on the product and applicable regulatory requirements, available documentation may include:

• EU Declaration of Conformity
• CE-related conformity documentation
• ISO certificates
• EUDAMED-related documentation
• MDR 2017/745 documentation
• Product labels and identification information
• Instructions for Use
• Batch, lot or serial information
• Manufacturer information
• Other applicable regulatory records

7. Product Identification & Traceability

Where applicable, product records may include batch, lot, serial number, manufacturer information, product codes or other identifiers designed to support product traceability.

Customers should retain invoices, product labels and related documentation, particularly for medical devices and professional-use products.

8. Manufacturer Documentation

For products manufactured by third parties, regulatory and conformity documentation may originate from the relevant legal manufacturer or authorised economic operator.

Capilux Medical may maintain or provide relevant documentation where required for legitimate commercial, regulatory or customer purposes.

9. Product-Specific Compliance

Regulatory requirements vary depending on product classification, intended use, manufacturer, market and applicable legislation.

Customers should therefore rely on the documentation applicable to the specific product rather than assuming that every certification or regulatory status displayed on this page applies to every item in the catalogue.

10. Document Verification

Professional customers, clinics, distributors and other authorised commercial partners may contact Capilux Medical to request available regulatory or quality documentation relating to specific products.

Documentation may be supplied subject to confidentiality, regulatory, manufacturer or commercial restrictions where applicable.

11. Continuous Compliance

Regulatory documentation and certification may be updated as legislation, standards, product classifications, manufacturers or certification requirements change.

Capilux Medical aims to maintain current documentation relevant to its activities and the products it supplies.

12. Quality & Regulatory Enquiries

For quality, regulatory or certification enquiries, please contact: