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Declaration of conformity

SALIN devices’ manufacturer, S.C. TEHNO BIONIC SRL, with its registered office in 55 Agriculturii Street, Buzău / Phone: 0238 725 321, declares on its own responsibility that the product: SALINE AIR PURIFICATION DEVICE, “SALIN” TYPE, CLASS I, referred to in this declaration, observes the protection requirements and complies with the following standards:

GD 54/2009 on the conditions for placing medical devices on the market, Schedule I and Schedule VII.

The following harmonized standards, SR or technical specification:

  • SR EN 60601-1: 2007, Medical electrical equipment.

Part 1-1: General requirements for basic safety and essential performance:

  • SR EN 60601-1-2: 2007, Medical electrical equipment.

Part 2: General security requirements. Collateral standard: Electromagnetic compatibility. Requirements and tests:

  • Technical specification no. 4/2011.

The devices are registered as medical devices by MSP with certificate no. RO / I-020-019-2007.

Declaratie de conformitate
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