Compliances

It has passed through the most stringent Safety and Compliance Tests

Ozone Emission Test : no. 2306-50-1 dated 16.05.2020
(by SSTx LLC)

Ozone Emission Test No Ozone Emission
Household and  Similar Electrical Appliances – Safety – no. 4789499873 dated 26.06.2020 (by UL)
IEC 60335 1:2010 Passed
COR1:2010 Passed
COR2:2011 Passed
AMD1:2013 Passed
COR1:2014 Passed
AMD2:2016 Passed
COR1:2016 Passed

Electrical Equipment for measurement, control and laboratory use – EMC requirement : no. 4789460695-NABL-S1 dated 29.04.2020 (by UL)

CISPR 11 Conductance Disturbance/ Radiated Disturbances Passed
IEC 61000-3-2 Harmonics Current Emissions Passed
IEC 61000-3-3 Voltage Fluctuations and Flicker Emissions Passed
IEC 61000-4-2 Electrostatic Discharge Passed
IEC 61000-4-3 Radiated RF disturbance Passed
IEC 61000-4-4 Electrical Fast Transient Passed
IEC 61000-4-5 Surge Immunity Passed
IEC 61000-4-4 Immunity to conducted disturbance Passed
IEC 61000-4-4 Power Frequency Magnetic Field Passed
IEC 61000-4-4 Voltage Dips & Short Interruptions Passed
2014/30/EU – Electromagnetic Compatibility Directive 2014/30/EU – Low Voltage Directive IEC 61326-1: 2012 - Immunity and emissions regarding electromagnetic compatibility (EMC)

Scientific evidence of efficacy for viral particles in the air and surface

Tested against Infective SARS-CoV-2 Virus by a Leading European BSL-3 Laboratory.

Scientific studies have established that the SARS-CoV-2 virus* remains active on a Stainless Steel surface for more than 72 hours. Research by a prestigious European BSL-3 Laboratory shows that on Stainless Steel surfaces, Scalene SHYCOCAN® reduces the SARS-CoV-2 virus* by 94.9% in just 15 minutes.

Type of Study Institution Name Virus/Bacteria/Fungi/Cells Used Report Reference Aim Of Study Study Conclusion
Virology Study 1 Laboratorios de Especialidades Immunológicas S.A de C.V - Mexico Equine arteritis virus ATCC VR-76 44527 Neutralizing of SARS-CoV-2,surrogate viral particles Eliminates 99.9% of the virus
Virology Study 2 Laboratorios de Especialidades Immunológicas S.A de C.V - Mexico INFLUENZA-B virus ATCC VR-1535 RN44527 Assess he effect of Shycocan and resultant viral activity Shycocan eliminates the Influenza-B virus
Virology Study 3 Aquadiagnostics an IAPMO group - USA Bacteriophage – MS2 Phage 80CC15597B1 AWRTCL/17618A/20-21 To assess the microbial reduction capability 99.976%, 99.994%, 99.996% pfu in 30 mins, 1 hr, 2 hrs
Virology Study 4 Aquadiagnostics an IAPMO group - USA Bacteriophage – MS2 Phage 80CC15597B1 AWRTCL/PRTR/17822/20201 Fast response of MS2 Phage contaminated planks exposed to the Shycocan Capable of reducing MS2 Phage counts to 99.61% to 99.74% in time intervals of 60 s, 5 and 10 mins
Virology Study 5 Aquadiagnostics an IAPMO group - USA Bacteriophage – MS2 Phage 80CC15597B1 AWRTCL/PRTR/17819A/20-21 Study effect of Shycocan  on MS2 Phage in 17000 cubic feet Exposure at different heights from floor to 11ft did not have significant impact on the efficacy of the device
Virology Study 6 Indian Institute Of Technology (IIT) – Guwahati, India Avian Coronavirus CLE-EFL-SS11 Study the neutralizing and disinfection efficacy Viral inactivation was 100% in the Air at exposure time of 15 mins and 120 mins
Bacterial and Fungal Study 1 Microbiology Laboratory – Scalene Energy Research Institute, Bangalore, India Bacillus. Subtilis SCRI073120-B/2020 To determine if Shycocan exposure has any bactericidal effect on useful bacterium No bactericidal activity, no decrease in number of colonies and number of bacterial cells
Bacterial and Fungal Study 2 Microbiology Laboratory – Scalene Energy Research Institute, Bangalore, India Saccharomyces Cerevisiae SCRI073120-F/2020 dated 31/07/2020 If Shycocan exposure would affect the viability of fungal reduction Does not interfere with the physiology/viability of the tested fungus
Toxicology Study 1 Indian Institute Of Technology (IIT) – Guwahati, India Human Alveolar Basal Epithelial Cells (A549) CLE-EFL-SS014 To assess toxicity of Shycocan on human cell lines The Shycocan is non-toxic to human cells
Toxicology Study 2 University Of Madras, India Vero Cells (African green monkey kidney epithelial cells) Report Dates 10-Dec-2020 To assess toxicity of Shycocan on Vero Cells The Shycocan is non-toxic to Vero Cells.

SCALENE SHYCOCAN® already conforms to the regulatory requirements across countries

  • CE Mark with Class I Classification.
  • SCALENE SHYCOCAN® is currently market-enabled as per the U.S. FDA’s “Enforcement Discretion Guidance” during the COVID-19 Public Health Emergency.
  • Australian TGA has considered this device as excluded goods under Therapeutic Goods Determination 2018, schedule I, item 12-Environmental Control/Detoxification Equipment.
  • MEDSAFE, considers SCALENE SHYCOCAN® as not falling into the definition of medical device in New Zealand. Hence by proper labelling norms and ensuring its safety and effectiveness and compliance with Fair Trading Act 1996 and Consumer Guarantee Act 1993, the device may be made available in New Zealand.
  • DGHS-CDSCO, India: Class A device: Registration No: MFG/MD/2020/27975.
  • Product has received the Certificate of Conformity under the Emirates Conformity Assessment Scheme (ECAS) from the Emirates Authority for Standardization and Metrology (ESMA) based on compliance to the following requirements: UAE RoHS Decision No.10 of 2017 (Certificate No. 20-11-29685/E20-11-007514).
  • Energy Commission of Malaysia has confirmed that this product is NOT CONTROLLED by ST and does not require a COA permit.

The indications on the products and / or their packaging signifies that Scalene Cybernetics Limited, India holds the reference technical files of complete documentation, available to the concerned authorities.

*SCALENE SHYCOCAN® is Scientifically Evidenced to Attenuate/Neutralise 99.994% of Viral particles on Surfaces (MS2 Phage) and 100% in Air (Avian Coronavirus), and reduce 94.9% OF SARS-CoV-2 on stainless steel surfaces in just 15 minutes.