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Volista - EUDAMED Registration 03700712434519

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 03700712434519 and manufactured by Maquet SAS in France.

This page provides complete registration details including trade name (VSTII40SF 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.

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EUDAMED Official Data
Class I
03700712434519
Yes
Volista
Trade Name: VSTII40SF XHD127 SAX1216
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Device Description (EMDN)

FIXED SCIALYTIC LAMPS

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Z12010701
Trade Name
VSTII40SF XHD127 SAX1216
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
03700712434519
Basic UDI
3700712432614RZ
Version Date
February 18, 2025
Manufacturer Last Update
February 04, 2022
Active Status
Yes
Manufacturer
Manufacturer Name
Maquet SAS
Country
France
Country Type
EU_MEMBER_STATE
Address
Parc de Limère - Avenue de la Pomme de Pin ARDON
Email
pascal.jay@getinge.com
Regulatory Information
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
Device Characteristics
Human Tissues
No
Animal Tissues
No