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Oxygen concentrator - EUDAMED Registration 06934822533429

Access comprehensive regulatory information for Oxygen concentrator 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 06934822533429 and manufactured by Jiangsu Konsung Bio-Medical Science And Technology Co.,Ltd. in China.

This page provides complete registration details including trade name (Philips), manufacturer information, authorized representative details, competent authority (DE/CA05 - Behorde fur Justiz und Verbraucherschutz), 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
06934822533429
Yes
Oxygen concentrator
Trade Name: Philips
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Device Description (EMDN)

OXYGEN CONCENTRATORS

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Z12159004
Trade Name
Philips
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06934822533429
Basic UDI
B-06934822533429
Active Status
Yes
Manufacturer
Country
China
Country Type
NON_EU
Address
NO. 8 Shengchang West Road, Danyang Development Zone Danyang Development Zone, Jiangsu Province
Email
libaohong@konsung.com
Authorized Representative
SRN
DE-AR-000000001
Country
Germany
Address
80 Eiffestraße Hamburg
Email
shholding@hotmail.com
Telephone
+49 40 2513175
Regulatory Information
Competent Authority
DE/CA05 - Behorde fur Justiz und Verbraucherschutz
Applicable Legislation
MDD (Directive 93/42/EEC 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, Türkiye:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No