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OCTOTM - EUDAMED Registration 08809294291635

Access comprehensive regulatory information for OCTOTM 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 08809294291635 and manufactured by DalimsurgNET corporation in Republic of Korea.

This page provides complete registration details including trade name (OCTOTM), 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
08809294291635
No
OCTOTM
Trade Name: OCTOTM
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Device Description (EMDN)

MINIMALLY INVASIVE SURGERY SPREADERS AND RETRACTORS, SINGLE-USE

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
K01020106
Trade Name
OCTOTM
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
08809294291635
Basic UDI
B-08809294291635
Version Date
February 07, 2023
Manufacturer Last Update
October 18, 2021
Active Status
No
Manufacturer
Manufacturer Name
DalimsurgNET corporation
Country
Republic of Korea
Country Type
NON_EU
Address
B708 & 1002, 583, Yangcheon ro, Gangseo gu Seoul
Email
ince85@dalimsurg.net
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
France
Market Available
France:2012-09-01~None
Device Characteristics
Human Tissues
No
Animal Tissues
No