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Aladin2 Sevoflurane Easy-Fil - EUDAMED Registration 00840682100298

Access comprehensive regulatory information for Aladin2 Sevoflurane Easy-Fil in the European Union medical device market through Pure Global AI's free database. This Class IIb device is registered with EU EUDAMED under Primary DI 00840682100298 and manufactured by Datex-Ohmeda Inc. in United States.

This page provides complete registration details including trade name (Aladin2 Sevoflurane Easy-Fil), manufacturer information, authorized representative details, 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 IIb
00840682100298
Yes
Aladin2 Sevoflurane Easy-Fil
Trade Name: Aladin2 Sevoflurane Easy-Fil
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Device Description (EMDN)

ANAESTHESIA SYSTEMS - HARDWARE ACCESSORIES

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
Z1203010180
Trade Name
Aladin2 Sevoflurane Easy-Fil
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00840682100298
Basic UDI
B-00840682100298
Version Date
March 21, 2024
Manufacturer Last Update
July 20, 2023
Active Status
Yes
Manufacturer
Manufacturer Name
Datex-Ohmeda Inc.
Country
United States
Country Type
NON_EU
Address
3030 Ohmeda Drive 7550 Madison
Email
jim.raskob@med.ge.com
Authorized Representative
SRN
FI-AR-000017101
Country
Finland
Address
2 Kuortaneenkatu Helsinki
Email
CoE.Postmarket@ge.com
Regulatory Information
Competent Authority
Agence Nationale de Sécurité du Médicament et des Produits de Santé
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Finland
Market Available
Austria:None~None, Belgium:None~None, Bulgaria:None~None, Croatia:None~None, Cyprus:None~None, Czechia:None~None, Denmark:None~None, Estonia:None~None, Finland:None~None, France:None~None, Germany:None~None, Greece:None~None, Hungary:None~None, Iceland:None~None, Ireland:None~None, Italy:None~None, Latvia:None~None, Liechtenstein:None~None, Lithuania:None~None, Luxembourg:None~None, Malta:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Slovakia:None~None, Slovenia:None~None, Spain:None~None, Sweden:None~None, Türkiye:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No