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ARKRAY Factory, Inc. - Manufacturer Profile

Explore comprehensive manufacturer profile for ARKRAY Factory, Inc. through Pure Global AI's free EU medical device database. This company manufactures 391 medical devices registered with EUDAMED across 4 risk classes based in Japan.

This page provides detailed insights including recent registrations, risk class distribution (IVD General: 198, IVD Annex II List B: 133, IVD devices for self-testing: 4, Class A: 56), and complete regulatory information from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry.

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391 Devices
4 Risk Classes
ARKRAY Factory, Inc.
Manufacturer - Japan
391
Total Devices
4
Risk Classes
2022
Earliest Version
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Recent Products (Latest 10)
Most recently updated devices in the database
Device NameRisk ClassDetail
SpotChem D-Concept 2e (SD-4840)
Class A
SpotChem D-Concept 2c (SD-4830)
Class A
OSMO STATION 2 (OM-6070)
IVD General
AutionIDaten (AE-4070)
Class A
GLUCOCARD S
IVD Annex II List B
PochetChem Printer
Class A
GLUCOCARD S Test Strips
IVD Annex II List B
GLUCOCARD S Test Strips
IVD Annex II List B
GLUCOCARD S Test Strips
IVD Annex II List B
GLUCOCARD S onyx (GT-7120)
IVD Annex II List B
Risk Class Distribution
Breakdown by risk classification
IVD General
198(50.6%)
IVD Annex II List B
133(34.0%)
Class A
56(14.3%)
IVD devices for self-testing
4(1.0%)
Top Authorized Representatives
Most common authorized representatives for this manufacturer
Authorized RepresentativeDevice CountPercentageView
ARKRAY Europe, B.V.
391100.0%