UVC disinfection technologies with regulatory approval. One line is a mobile room-scale tower; the other is an enclosed cabinet for instruments and objects.

Regulatory status

Standards & approvals

Bodies & standards

May 2025: Simbona's products received EFDA market authorisation and registration.

EFDA
Ethiopian Food & Drug Authority
ECAE
Ethiopian Conformity Assessment Enterprise
IEC
International Electrotechnical Commission
IES
Institute of Ethiopian Standards
ETA
Ethiopian Technology Authority

Directives

93/42/EEC Medical Devices Directive and amendment 2007/47/EC
Conformity assessment procedure per Article 11.3.a

Standards applied

IEC 60601-1:2005
IEC 60601-2-21:2009
IEC 60601-1-2:2007
ISO 9001:2007
EFDA Guideline for Registration Requirements of Medical Devices other than In Vitro Diagnostic Devices

This device

Regulatory body: EFDA
Date granted: May 2025

Procurement

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Simbona

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