Pure Global AI
EUDAMED registration 08904443038267No

NOVA AI 1.53

Vision Rx Lab Private LimitedClass IEU EUDAMEDTrade name: Nova
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class I
CND nomenclatures code
Q0210010103
Trade name
Nova
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
08904443038267
Basic UDI
890444301.53NVAICL99
Version date
October 15, 2024
Manufacturer last update
July 28, 2022
Active status
No
Manufacturer
Manufacturer name
Vision Rx Lab Private Limited
Country
India
Country type
NON_EU
Address
Phase I P4, Kasba Industrial Estate KOLKATA
Email
anupamchowdhury@vrxlab.com
Authorized representative
Name
Obelis s.a.
SRN
BE-AR-000000106
Country
Belgium
Address
53 Boulevard Général Wahis Brussels
Email
regulatory@obelis.net
Telephone
+32(2)73 25 954
Regulatory information
Competent authority
Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten/ Afdeling Gezondheidsproducten
Applicable legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed on the market
Croatia
Market available
Austria:2022-07-29~2029-12-31, Belgium:2022-07-29~2029-12-31, Bulgaria:2022-07-29~2029-12-31, Croatia:2022-07-29~2029-12-31, Cyprus:2022-07-29~2029-12-31, Czechia:2022-07-29~2029-12-31, Denmark:2022-07-29~2029-12-31, Estonia:2022-07-29~2029-12-31, Finland:2022-07-29~2029-12-31, France:2022-07-29~2029-12-31, Germany:2022-07-29~2029-12-31, Greece:2022-07-29~2029-12-31, Hungary:2022-07-29~2029-12-31, Iceland:2022-07-29~2029-12-31, Ireland:2022-07-29~2029-12-31, Italy:2022-07-29~2029-12-31, Latvia:2022-07-29~2029-12-31, Liechtenstein:2022-07-29~2029-12-31, Lithuania:2022-07-29~2029-12-31, Luxembourg:2022-07-29~2029-12-31, Malta:2022-07-29~2029-12-31, Netherlands:2022-07-29~2029-12-31, Norway:2022-07-29~2029-12-31, Poland:2022-07-29~2029-12-31, Portugal:2022-07-29~2029-12-31, Romania:2022-07-29~2029-12-31, Slovakia:2022-07-29~2029-12-31, Slovenia:2022-07-29~2029-12-31, Spain:2022-07-29~2029-12-31, Sweden:2022-07-29~2029-12-31, Türkiye:2022-07-29~2029-12-31, United Kingdom (Northern Ireland only):2022-07-29~2029-12-31
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

PROGRESSIVE ORGANIC OPHTHALMIC LENSES

About this record

Access comprehensive regulatory information for NOVA AI 1.53 in the European Union medical device market through Pure Global AI's free database. This Class I device is registered with EU EUDAMED under Primary DI 08904443038267 and manufactured by Vision Rx Lab Private Limited in India.

This page provides complete registration details including trade name (Nova), manufacturer information, authorized representative details, competent authority (Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten/ Afdeling Gezondheidsproducten), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.