EUDAMED registration 08904443006129NoGeneric SV 1.60 Sph
- Risk class
- Class I
- CND nomenclatures code
- Q0210010101
- Trade name
- Nova
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 08904443006129
- Basic UDI
- 89044430PL16SRXMW
- Version date
- December 05, 2024
- Manufacturer last update
- July 28, 2022
- Active status
- No
- Manufacturer name
- Vision Rx Lab Private Limited
- Country
- India
- Country type
- NON_EU
- Address
- Phase I P4, Kasba Industrial Estate KOLKATA
- anupamchowdhury@vrxlab.com
- Name
- Obelis s.a.
- SRN
- BE-AR-000000106
- Country
- Belgium
- Address
- 53 Boulevard Général Wahis Brussels
- regulatory@obelis.net
- Telephone
- +32(2)73 25 954
- 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
- Human tissues
- No
- Animal tissues
- No
MONOFOCAL ORGANIC OPHTHALMIC LENSES
Access comprehensive regulatory information for Generic SV 1.60 Sph 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 08904443006129 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.