Regulatory

Registrations for product labelling

• Class I medical device
• MHRA Registration Number: 12834 - PARD
• FDA Registration number: 3014329625 - FDA
• EU Single Registration Number (SRN): GB-MF-000025198 - EUDAMED
• Basic UDI-DI (GMN): 5065017576AOS5C

Authorised European Representative

MDSS, Medical Device Safety Service GmbH, Schiffgraben 41, 30175 Hannover, Germany

MDR / EU Notified Body

TUVSUD, Napier Building, Scottish Enterprise Technology Park, East Kilbride, Glasgow. G75 0QF United Kingdom

Certifications

ISO/IEC 27001:2022 Certification

• Amtivo Certificate
• Download

U.S. Info

• External Ocular photography & AOS Anterior (Corcoran Consultancy Group, June 2020)
• External Ocular photography & CPT codes (Corcoran Consultancy Group, June 2020)

External links

• Evaluating a new objective grading software for conjunctival hyperaemia
  (Huntjens, B., Basi, M. and Nagra, M. - 2019)