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EUDAMED registration 06945934602910No

Urine Drainage Bag

Changzhou Huankang Medical Device Co., Ltd.Class IEU EUDAMEDTrade name: urine drainage bag
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class I
CND nomenclatures code
A06030301
Trade name
urine drainage bag
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
06945934602910
Basic UDI
69459346udbGQ
Version date
September 13, 2024
Manufacturer last update
July 01, 2021
Active status
No
Manufacturer
Manufacturer name
Changzhou Huankang Medical Device Co., Ltd.
Country
China
Country type
NON_EU
Address
22 Changhe Road, Sanhekou, Zhenglu, Changzhou, Jiangsu,
Email
Paul.zhai@huankang.com
Authorized representative
Name
SUNGO Europe B.V.
SRN
NL-AR-000000247
Country
Netherlands
Address
Fascinatio Boulevard 522, Unit 1.7 Capelle aan den IJssel
Email
ec.rep@sungoglobal.com
Regulatory information
Competent authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed on the market
Spain
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

URINE COLLECTION BAGS

About this record

Access comprehensive regulatory information for Urine Drainage Bag in the European Union medical device market through Pure Global AI's free database. This Class I device is registered with EU EUDAMED under Primary DI 06945934602910 and manufactured by Changzhou Huankang Medical Device Co., Ltd. in China.

This page provides complete registration details including trade name (urine drainage bag), 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.