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EMPIRE microIncision Needle Electrodes - EUDAMED Registration 00841494102951

Access comprehensive regulatory information for EMPIRE microIncision Needle Electrodes 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 00841494102951 and manufactured by Cynosure LLC in United States.

This page provides complete registration details including trade name (EMPIRE microIncision Needle Electrodes), 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
Class IIb
00841494102951
No
EMPIRE microIncision Needle Electrodes
Trade Name: EMPIRE microIncision Needle Electrodes
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Device Description (EMDN)

OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
K0201010301
Trade Name
EMPIRE microIncision Needle Electrodes
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00841494102951
Basic UDI
B-00841494102951
Version Date
January 04, 2023
Manufacturer Last Update
May 20, 2022
Active Status
No
Manufacturer
Manufacturer Name
Cynosure LLC
Country
United States
Country Type
NON_EU
Address
5 Carlisle Road Westford
Email
nikunj.patel@cynosure.com
Authorized Representative
SRN
NL-AR-000009566
Country
Netherlands
Address
143 Veemarkt Amsterdam
Email
ECREP@cynosure.com
Regulatory Information
Competent Authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Netherlands
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, Turkey:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No