Upretina
Institutional information

Regulatory affairs

Information about the manufacturer, the UpRetina medical device, its certification status and the applicable regulatory framework.

Manufacturer identification

OPT RETINA, S.L. develops and manufactures healthcare software and operates under a medical-device manufacturer license issued by AEMPS.

Company name
OPT RETINA, S.L.
Registered address
C/ Las Palmas, 11, 08195 Sant Cugat del Valles (Barcelona, Spain)
AEMPS license number
6887-PS
SRN
ES-MF-000019568
Email
info@upretina.com

Intended purpose of UpRetina

UpRetina is a standalone medical device software intended to support healthcare professionals in retina screening and early detection through the analysis of fundus images captured with non-mydriatic cameras, in order to support referral decisions to ophthalmology specialists.

Technical and commercial product information is intended exclusively for qualified healthcare professionals. Access to professional content is controlled beforehand.

CE marking and certification status

The products currently in commercialization bear CE marking as class I medical devices in accordance with Directive 93/42/EEC.

UpRetina, classified as a class IIa medical device (Regulation (EU) 2017/745, Rule 11 of Annex VIII), is undergoing conformity assessment by a notified body to obtain CE marking under the MDR.

Healthcare activity and authorized center

OPT RETINA, S.L. is a healthcare software manufacturer and is not an in-person healthcare center. The reading and clinical assessment of the retinal images is carried out by licensed ophthalmologists specialized in retina, who are responsible for the medical act in accordance with the lex artis.

This teleophthalmology activity is carried out within an authorized healthcare center registered in the Registry of healthcare centers, services and establishments (REGCESS): Institut d'Oftalmologia Clínica Girona (OFTALIS), authorized by the Departament de Salut of the Generalitat de Catalunya.

To preserve referral independence, the reports do not contain references to specific ophthalmology centers.

Center
Institut d'Oftalmologia S.L.P. (OFTALIS)
Trade name
Institut d'Oftalmologia Clínica Girona
Address
C/ Juli Garreta, 13-15, 17002 Girona (inside Clínica Girona, COC H17001491)
Tax ID
B-17356932
REGCESS code
E17610503
Authorization file
98588
Authorization date
7 July 2017

Applicable regulatory framework

  • Regulation (EU) 2017/745 (MDR) on medical devices; in particular Article 7, on claims about the product.
  • Directive 93/42/EEC on medical devices; the framework applicable to the legacy CE-marked products currently in commercialization.
  • Royal Decree 192/2023, regulating medical devices.
  • Royal Decree 1591/2009, as regards the advertising of medical devices, kept transitionally in force by Royal Decree 192/2023 until its specific implementing legislation.
  • Royal Legislative Decree 1/2015, consolidated text of the Law on guarantees and rational use of medicines and medical devices.
  • Royal Decree 1907/1996, on the advertising and commercial promotion of products, activities or services with a purported health purpose.
  • Law 34/1988, General Advertising Law.
  • Law 14/1986, General Health Law.
  • Law 44/2003, on the regulation of the health professions.
  • Catalan Government guidance, 3rd edition (October 2024), on requirements and conditions for advertising medical devices to the public.
  • ORDRE SLT/144/2017 on public health advertising in Catalonia.
Last update: June 2026