QUALITY ACCREDITATIONS
Our desire to offer our clients a proven guarantee and reliability has led us to obtain several accreditations, both locally and internationally.
EUROPE
Take a look at the certifications and registrations we have that are valide in Europe.
Italy/Europe
Approval by the Istituto Superiore di Sanità (NB0373) and Eurofins Product Testing Italy S.r.l. (NB0477) of the Quality Assurance system for the production of class IIa, IIb and III Medical Devices.
Italy/Europe
​Quality Management System certified according to the standards:
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UNI EN ISO 9001: 2015 Certificate (Quality Management Systems) No. 50100 7070 issued by TÜV SÜD Italy. Download
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ISO 13485: 2016 Certificate (Medical Devices) No. Q5063353 0009 issued by TÜV SÜD Munich. Download
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ISO 22716: 2008 Certificate (Cosmetics) No. 50 100 14 852/COS issued by TÜV SÜD Italy. Download
Italy
“Cosmetic Products Notification Portal” (CPNP) notification pursuant to regulation 1223/2009. Production and packaging of cosmetic products.
UK - Rep HL Healthcare Limited
Pressence of Quality Assurance and Regulatory Affairs units.
WORLDWIDE
Our quality is recognized all around the world, let our certifications and registrations speak for us:
Worldwide
Halal certification issued by World Halal Authority - WHA.
Worldwide
​N° 00028125 Certification at Grade AA applicable to Product Category 07 – Issued by LRQA ITALY S.R.L.
Canada
CMDCAS HEALTH CANADA - Manufacturing of Medical Devices. Certificate ISO 13485: 2016 No. QS1 063353 0008 issued by TÜV SÜD AMERICA INC.
USA
FDA Registration No. 3005488444 - Manufacturing of Medical Devices (NTO, MGQ, FRO).
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Cosmetic Products Registrations (MoCRA)
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Drug OTC Monography Registrations
USA
Presence of an USA Agent (Registrar Corp).
Brazil
GMP Certificate issued by ANVISA (Agência Nacional de Vigilância Sanitária).
Australia, Brazil, Canada & United States
MDSAP ISO 13485:2016 Certificate No. QS6 063353 0010 issued by TÜV SÜD AMERICA INC. Download
Israel
Inclusion in the Medical Devices Register of the Ministry of Health for the State of Israel; approval N° 227760001.
United Arab Emirates
Production site certification No. 03733C01 at the Ministry of Health of the United Arab Emirates - Production of GSL products.
South Korea
GMP certificate issued by the Korean FDA - Production of Medical Devices.
Japan
Certificate No. BG22000286 issued by the Japan Ministry of Health, Labor and Welfare - Production of Medical Devices.
Australia
Certification of conformity
by the "Australian Government", TGA
AU T00004/01. Assessment by the notified body N°0805
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NOTIFIED BODIES THAT HAVE ACCREDITED US
Take a look at the notified bodies that have accredited us due to the quality of our processes:
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