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AutionIDaten (AE-4070) - EUDAMED Registration 04987486043751

Access comprehensive regulatory information for AutionIDaten (AE-4070) 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 04987486043751 and manufactured by ARKRAY Factory, Inc. in Japan.

This page provides complete registration details including trade name (AutionIDaten (AE-4070)), 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
04987486043751
No
AutionIDaten (AE-4070)
Trade Name: AutionIDaten (AE-4070)
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Device Description (EMDN)

SEMI-AUTOMATED URINE ANALYSERS

Device Classification
Risk Class
Class A
CND Nomenclatures Code
W020101020102
Trade Name
AutionIDaten (AE-4070)
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
04987486043751
Basic UDI
4987486BC0108412GR
Version Date
May 11, 2023
Manufacturer Last Update
April 08, 2022
Active Status
No
Manufacturer
Manufacturer Name
ARKRAY Factory, Inc.
Country
Japan
Country Type
NON_EU
Address
1480 Koji Konan-cho, Koka-shi, Shiga
Email
support_arkrayeurope@arkray.co.jp
Authorized Representative
SRN
NL-AR-000002056
Country
Netherlands
Address
Prof. J.H. Bavincklaan 2 Amstelveen
Email
support_ArkrayEurope@arkray.co.jp
Telephone
+31 205452450
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
Ireland
Market Available
Austria:None~None, Belgium:None~None, Cyprus:None~None, Czechia:None~None, France:None~None, Germany:None~None, Greece:None~None, Hungary:None~None, Ireland:None~None, Italy:None~None, Liechtenstein:None~None, Lithuania:None~None, Luxembourg:None~None, Malta:None~None, Netherlands:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Slovakia:None~None, Slovenia:None~None, Spain:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No