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EUDAMED registration 06923980104268No

Disposable Anesthesia Circuit

GaleMed (Xiamen) Co., Ltd.Class IIaEU EUDAMED
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class IIa
CND nomenclatures code
R02010101
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
06923980104268
Basic UDI
69239801ND2BGNV
Version date
January 05, 2024
Manufacturer last update
February 21, 2022
Active status
No
Manufacturer
Manufacturer name
GaleMed (Xiamen) Co., Ltd.
Country
China
Country type
NON_EU
Address
Xiamen Area of China (Fujian) Pilot Free Trade Zone, Xiamen
Email
xm_qa@galemed.com
Authorized representative
Name
Emergo Europe B.V.
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
Malta
Market available
Malta:None~None
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

BREATHING CIRCUITS, W/O WATER TRAP

About this record

Access comprehensive regulatory information for Disposable Anesthesia Circuit 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 06923980104268 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.