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Mag-Bind RNA Extraction Kit - EUDAMED Registration 06950617443452

Access comprehensive regulatory information for Mag-Bind RNA Extraction Kit 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 06950617443452 and manufactured by Maccura Biotechnology Co., Ltd. in China.

This page provides complete registration details including trade name (Mag-Bind RNA Extraction Kit), 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
06950617443452
No
Mag-Bind RNA Extraction Kit
Trade Name: Mag-Bind RNA Extraction Kit
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Device Description (EMDN)

REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS

Device Classification
Risk Class
Class A
CND Nomenclatures Code
W0105900101
Trade Name
Mag-Bind RNA Extraction Kit
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06950617443452
Basic UDI
69506174GN710903DQ
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
NL-AR-000001490
Country
Netherlands
Address
701 Joop Geesinkweg Amsterdam-Duivendrech
Email
ce-tech@humiss.com
Telephone
+31 (0)20 369 8116
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