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Disposable Aerosol therapy - EUDAMED Registration 06923980105401

Access comprehensive regulatory information for Disposable Aerosol therapy 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 06923980105401 and manufactured by GaleMed (Xiamen) Co., Ltd. in China.

This page provides complete registration details including manufacturer information, authorized representative details, competent authority (Ministerie van Volksgezondheid, Welzijn en Sport), 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
06923980105401
No
Disposable Aerosol therapy
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

AEROSOL THERAPY KITS

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
R03010304
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06923980105401
Basic UDI
69239801FD2AAKN
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
Xiamen Area of China (Fujian) Pilot Free Trade Zone, Xiamen
Email
xm_qa@galemed.com
Authorized Representative
SRN
NL-AR-000000116
Country
Netherlands
Address
60 Westervoortsedijk Arnhem
Email
lst.aus.euauthrep@ul.com
Telephone
+31 70 345 8570
Regulatory Information
Competent Authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Germany
Market Available
Germany:2023-03-31~2027-12-08
Device Characteristics
Human Tissues
No
Animal Tissues
No