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Sample Diluent No.5 - EUDAMED Registration 06950617475392

Access comprehensive regulatory information for Sample Diluent No.5 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 06950617475392 and manufactured by Maccura Biotechnology Co., Ltd. in China.

This page provides complete registration details including trade name (Sample Diluent No.5), 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 A
06950617475392
No
Sample Diluent No.5
Trade Name: Sample Diluent No.5
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Device Description (EMDN)

BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)

Device Classification
Risk Class
Class A
CND Nomenclatures Code
W01029003
Trade Name
Sample Diluent No.5
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06950617475392
Basic UDI
69506174IM420466DG
Version Date
February 14, 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 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