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Automatic Hematology Analyzer - EUDAMED Registration 06972168350300

Access comprehensive regulatory information for Automatic Hematology Analyzer in the European Union medical device market through Pure Global AI's free database. This IVD General device is registered with EU EUDAMED under Primary DI 06972168350300 and manufactured by Maccura Medical Instrument Co., Ltd. in China.

This page provides complete registration details including trade name (Automatic Hematology Analyzer), 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
IVD General
06972168350300
No
Automatic Hematology Analyzer
Trade Name: Automatic Hematology Analyzer
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Device Description (EMDN)

AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 120 samples/hr)

Device Classification
Risk Class
IVD General
CND Nomenclatures Code
W0202010102
Trade Name
Automatic Hematology Analyzer
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06972168350300
Basic UDI
B-06972168350300
Version Date
November 04, 2024
Manufacturer Last Update
September 05, 2022
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
Building 4, 8#, 2nd Anhe Roda, Hi-tech Zone, 611731, Chengdu Chengdu
Email
maccura@maccura.com
Authorized Representative
SRN
DE-AR-000000001
Country
Germany
Address
80 Eiffestraße Hamburg
Email
shholding@hotmail.com
Telephone
+49 40 2513175
Regulatory Information
Competent Authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable Legislation
IVDD (Directive 98/79/EC on in vitro Diagnostic Medical Devices)
Placed On The Market
Italy
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