Pure Global

Urinalysis Hydrometer Cleaning Solution - EUDAMED Registration 06950617495048

Access comprehensive regulatory information for Urinalysis Hydrometer Cleaning Solution 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 06950617495048 and manufactured by Maccura Biotechnology Co., Ltd. in China.

This page provides complete registration details including trade name (Urinalysis Hydrometer Cleaning Solution), 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.

Free Database
Powered by Pure Global AI
EUDAMED Official Data
Class A
06950617495048
No
Urinalysis Hydrometer Cleaning Solution
Trade Name: Urinalysis Hydrometer Cleaning Solution
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Description (EMDN)

URINALYSIS (UR) - LABORATORY ANALYSERS - CONSUMABLES

Device Classification
Risk Class
Class A
CND Nomenclatures Code
W02010785
Trade Name
Urinalysis Hydrometer Cleaning Solution
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06950617495048
Basic UDI
69506174HU510904HA
Version Date
February 17, 2025
Manufacturer Last Update
November 23, 2023
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
16#, Baichuan Road, Hi-tech Zone, Chengdu
Email
maccura@maccura.com
Authorized Representative
SRN
ES-AR-000000293
Country
Spain
Address
C/ Horacio Lengo N18 Mรกlaga
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
Tรผrkiye
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, Tรผrkiye:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No