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TRAUS SERIES - EUDAMED Registration 08809260473805

Access comprehensive regulatory information for TRAUS SERIES in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI 08809260473805 and manufactured by SAESHIN PRECISION CO.,LTD. in Republic of Korea.

This page provides complete registration details including trade name (TRAUS SERIES), manufacturer information, authorized representative details, competent authority (Health Products Regulatory Authority, Medical Devices Department), 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 IIa
08809260473805
Yes
TRAUS SERIES
Trade Name: TRAUS SERIES
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Device Description (EMDN)

ELECTROSURGERY INSTRUMENTS, REUSABLE - OTHER

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
L1899
Trade Name
TRAUS SERIES
Implantable
No
Reusable
Yes
Measuring Function
No
Registration Information
Primary DI
08809260473805
Basic UDI
B-08809260473805
Version Date
July 07, 2023
Manufacturer Last Update
November 10, 2021
Active Status
Yes
Manufacturer
Country
Republic of Korea
Country Type
NON_EU
Address
52 secheon-ro 1 711814 daegu
Email
Traus@saeshin.com
Authorized Representative
SRN
IE-AR-000004258
Country
Ireland
Address
Unit 3D North Point House North Point Business Park New Mallow Road Cork
Email
ar@meridiusmedical.com
Telephone
+353 212066448
Regulatory Information
Competent Authority
Health Products Regulatory Authority, Medical Devices Department
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Belgium
Market Available
Belgium:None~None, Germany:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No