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Anesthesia Machine - EUDAMED Registration 00840682134910

Access comprehensive regulatory information for Anesthesia Machine 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 00840682134910 and manufactured by GE Medical Systems CO. Ltd in China.

This page provides complete registration details including trade name (9100c NXT), manufacturer information, authorized representative details, competent authority (Agence Nationale de Sรฉcuritรฉ du Mรฉdicament et des Produits de Santรฉ), 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
00840682134910
Yes
Anesthesia Machine
Trade Name: 9100c NXT
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Device Description (EMDN)

ANAESTHESIA DEVICES

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
Z1203010101
Trade Name
9100c NXT
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00840682134910
Basic UDI
8406821BUG00167HH
Version Date
May 28, 2024
Manufacturer Last Update
February 13, 2023
Active Status
Yes
Manufacturer
Country
China
Country Type
NON_EU
Address
19 ChangJiang Road WUXI
Email
JiongWu@ge.com
Authorized Representative
SRN
FR-AR-000000344
Country
France
Address
283 Rue de la Miniere BUC
Email
CoE.Postmarket@ge.com
Regulatory Information
Competent Authority
Agence Nationale de Sรฉcuritรฉ du Mรฉdicament et des Produits de Santรฉ
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Poland
Market Available
Croatia:None~None, Cyprus:None~None, Czechia:None~None, France:None~None, Greece:None~None, Ireland:None~None, Malta:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Spain:None~None, Tรผrkiye:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No