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High-concentration Oxygen Masks (Non-rebreathing oxygen mask - EUDAMED Registration 06941951007301

Access comprehensive regulatory information for High-concentration Oxygen Masks (Non-rebreathing oxygen mask in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI 06941951007301 and manufactured by Guangdong Ecan Medical Co., Ltd. in China.

This page provides complete registration details including manufacturer information, authorized representative details, competent authority (DE/CA23 - Regierungspräsidium Darmstadt Dezernat IV/Da 45.2), 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 IIa
06941951007301
No
High-concentration Oxygen Masks (Non-rebreathing oxygen mask
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

MASKS WITH RESERVOIR

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
R03010206
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06941951007301
Basic UDI
697336256NBM01JP
Version Date
August 18, 2023
Manufacturer Last Update
February 28, 2022
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
Building 1, No.222 Xindu Road,Chengjiao Street, ConghuaDistrict Guangzhou City,Guangdong Province
Email
hanliuyuan@ecanmed.com
Authorized Representative
SRN
DE-AR-000007996
Country
Germany
Address
11 Koenigsberger Strasse Muenster Hessen
Email
contact@glgi.de
Telephone
004960714977513
Regulatory Information
Competent Authority
DE/CA23 - Regierungspräsidium Darmstadt Dezernat IV/Da 45.2
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Austria
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, Turkey:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No