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OSMO STATION 2 (OM-6070) - EUDAMED Registration D-109223MR

Access comprehensive regulatory information for OSMO STATION 2 (OM-6070) 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 D-109223MR and manufactured by ARKRAY Factory, Inc. in Japan.

This page provides complete registration details including trade name (OSMO STATION 2 (OM-6070)), 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
D-109223MR
No
OSMO STATION 2 (OM-6070)
Trade Name: OSMO STATION 2 (OM-6070)
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Device Description (EMDN)

OSMOMETERS

Device Classification
Risk Class
IVD General
CND Nomenclatures Code
W02079017
Trade Name
OSMO STATION 2 (OM-6070)
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
D-109223MR
Basic UDI
B-109223MR
Version Date
November 28, 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
IVDD (Directive 98/79/EC on in vitro Diagnostic Medical Devices)
Placed On The Market
Ireland
Market Available
Ireland:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No