Volista
- Risk class
- Class I
- CND nomenclatures code
- Z12010701
- Trade name
- VSTII60SF TK XHD127 SAX1216
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 03700712434434
- Basic UDI
- 3700712432614RZ
- Version date
- December 10, 2024
- Manufacturer last update
- February 04, 2022
- Active status
- Yes
- Manufacturer name
- Maquet SAS
- Country
- France
- Country type
- EU_MEMBER_STATE
- Address
- Parc de Limère - Avenue de la Pomme de Pin ARDON
- pascal.jay@getinge.com
- Competent authority
- Agence Nationale de Sécurité du Médicament et des Produits de Santé
- Applicable legislation
- MDR (REGULATION (EU) 2017/745 on medical devices)
- Placed on the market
- France
- Market available
- Austria:None~None, Belgium:None~None, Bulgaria:None~None, Cyprus:None~None, Czechia:None~None, Germany:None~None, Denmark:None~None, Estonia:None~None, Greece:None~None, Spain:None~None, Finland:None~None, France:None~None, Croatia:None~None, Hungary:None~None, Ireland:None~None, Iceland:None~None, Italy:None~None, Liechtenstein:None~None, Lithuania:None~None, Luxembourg:None~None, Latvia:None~None, Malta:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Sweden:None~None, Slovenia:None~None, Slovakia:None~None, Türkiye:None~None, United Kingdom (Northern Ireland only):None~None
- Human tissues
- No
- Animal tissues
- No
FIXED SCIALYTIC LAMPS
Access comprehensive regulatory information for Volista 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 03700712434434 and manufactured by Maquet SAS in France.
This page provides complete registration details including trade name (VSTII60SF TK XHD127 SAX1216), manufacturer information, competent authority (Agence Nationale de Sécurité du Médicament et des Produits de Santé), 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.