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Reusable Non Sterile Electrosurgical Electrode with and Without Handle Cautery - EUDAMED Registration 08964000797051

Access comprehensive regulatory information for Reusable Non Sterile Electrosurgical Electrode with and Without Handle Cautery 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 08964000797051 and manufactured by Electro Range MFG Co in Pakistan.

This page provides complete registration details including trade name (ERMC), 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
08964000797051
Yes
Reusable Non Sterile Electrosurgical Electrode with and Without Handle Cautery
Trade Name: ERMC
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Device Description (EMDN)

OPEN ELECTROSURGERY ELECTRODES, REUSABLE

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
L180601
Trade Name
ERMC
Implantable
No
Reusable
Yes
Measuring Function
No
Registration Information
Primary DI
08964000797051
Basic UDI
B-08964000797051
Version Date
October 17, 2024
Manufacturer Last Update
July 06, 2023
Active Status
Yes
Manufacturer
Manufacturer Name
Electro Range MFG Co
Country
Pakistan
Country Type
NON_EU
Address
250M Ghuenky Stop Near Spiky Sports Daska Road Sialkot 381 Sialkot
Email
info@electrorange.com
Authorized Representative
SRN
IE-AR-000003999
Country
Ireland
Address
Stratton House, BISHOPSTOWN ROAD CORK
Email
tqmuk@aol.com
Telephone
+447545595464
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
Austria
Market Available
Austria:None~None, Belgium:None~None, Bulgaria:None~None, Croatia:None~None, Cyprus:None~None, Czechia:None~None, Denmark:None~None, Estonia:None~None, Finland:None~None, France:None~None, Germany:None~None, Greece:None~None, Hungary:None~None, Iceland:None~None, Ireland:None~None, Italy:None~None, Latvia:None~None, Liechtenstein:None~None, Lithuania:None~None, Luxembourg:None~None, Malta:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Slovakia:None~None, Slovenia:None~None, Spain:None~None, Sweden:None~None, Tรผrkiye:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No