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EUDAMED registration 06950617452744No

Urinalysis Sediment Detergent B

Maccura Biotechnology Co., Ltd. Class AEU EUDAMEDTrade name: Urinalysis Sediment Detergent B
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class A
CND nomenclatures code
W02010785
Trade name
Urinalysis Sediment Detergent B
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
06950617452744
Basic UDI
69506174HU510903H8
Version date
February 14, 2025
Manufacturer last update
November 23, 2023
Active status
No
Manufacturer
Manufacturer name
Maccura Biotechnology Co., Ltd.
Country
China
Country type
NON_EU
Address
16#, Baichuan Road, Hi-tech Zone, Chengdu
Email
maccura@maccura.com
Authorized representative
Name
CMC Medical Devices & Drugs SL
SRN
ES-AR-000000293
Country
Spain
Address
C/ Horacio Lengo N18 Málaga
Email
info@cmcmedicaldevices.com
Telephone
+34951214054
Regulatory information
Competent authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable legislation
IVDR (REGULATION (EU) 2017/746 on in vitro diagnostic medical devices)
Placed on the market
Türkiye
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
Device description (EMDN)

URINALYSIS (UR) - LABORATORY ANALYSERS - CONSUMABLES

About this record

Access comprehensive regulatory information for Urinalysis Sediment Detergent B in the European Union medical device market through Pure Global AI's free database. This Class A device is registered with EU EUDAMED under Primary DI 06950617452744 and manufactured by Maccura Biotechnology Co., Ltd. in China.

This page provides complete registration details including trade name (Urinalysis Sediment Detergent B), 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.