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ESU Gounding Plate - EUDAMED Registration 08809083943042

Access comprehensive regulatory information for ESU Gounding Plate in the European Union medical device market through Pure Global AI's free database. This Class IIb device is registered with EU EUDAMED under Primary DI 08809083943042 and manufactured by BIO PROTECH INC. in Republic of Korea.

This page provides complete registration details including 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 IIb
08809083943042
Yes
ESU Gounding Plate
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

ELECTROSURGERY DUAL PATIENT PADS (NEUTRAL ELECTRODES), SINGLE-USE

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
K02010202
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
08809083943042
Basic UDI
B-08809083943042
Version Date
January 20, 2025
Manufacturer Last Update
February 06, 2025
Active Status
Yes
Manufacturer
Manufacturer Name
BIO PROTECH INC.
Country
Republic of Korea
Country Type
NON_EU
Address
151-3 Donghwagongdan-ro Wonju-si, Gangwon-do
Email
jnh@protechsite.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
Spain
Market Available
France:None~None, Spain:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No