Regulatory & Quality

1. Conformity (CE / MDR)

Our medical devices bear the CE mark and are placed on the EU market in accordance with Regulation (EU) 2017/745 on medical devices (MDR). For each device or device family, an EU Declaration of Conformity is drawn up and available on request.

• Notified body: where required for the applicable device class, conformity assessment involves an EU notified body; details are available on request.
• EU Declaration of Conformity: available on request via info@equateinstruments.com.

2. Certifications

See also our Certifications overview.

3. UDI, EUDAMED & SRN

We apply Unique Device Identification (UDI) to our devices in accordance with the MDR.

• Basic UDI-DI / UDI-DI: assigned per device in accordance with the MDR.
• Single Registration Number (SRN): assigned by the competent authority; available on request.
• EUDAMED: our data is registered in the European Database on Medical Devices as its modules become mandatory (the first modules become mandatory on 28 May 2026).

4. Intended use / professional use only

Our instruments are intended to be used by trained healthcare and dental professionals in accordance with the applicable instructions for use and each device's intended purpose. They are not intended for use by the general public.

5. IFU & reprocessing / validation

Reusable instruments must be cleaned, disinfected and sterilised in accordance with our instructions for use before first and each subsequent use. Our reprocessing information is validated with reference to recognised standards, including EN ISO 17664-1 (information for processing), EN ISO 15883 (washer-disinfectors) and ISO 17665 (moist-heat sterilisation).

To obtain the current IFU for a product, contact info@equateinstruments.com or refer to the documentation supplied with the device.

6. Regulatory contact & responsibilities

• A person responsible for regulatory compliance (PRRC) is designated in accordance with MDR Article 15; contact details are available on request.
• As an EU-based manufacturer, we are not required to appoint an EU Authorised Representative.
• United States: distribution is supported by FDA establishment registration and, where required, a US Agent — [[PLACEHOLDER: US Agent details, if applicable]].
• United Kingdom: market access is supported by a UK Responsible Person and UKCA/UK conformity route where applicable — [[PLACEHOLDER: UK Responsible Person details, if applicable]].