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UltraQ Reflex Neo - EUDAMED Registration 09342395002223

Access comprehensive regulatory information for UltraQ Reflex Neo 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 09342395002223 and manufactured by Ellex Medical Pty Ltd in Australia.

This page provides complete registration details including trade name (UltraQ Reflex Neo), 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
09342395002223
Yes
UltraQ Reflex Neo
Trade Name: UltraQ Reflex Neo
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Device Description (EMDN)

NEODYMIUM SURGICAL LASER

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
Z12011017
Trade Name
UltraQ Reflex Neo
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
09342395002223
Basic UDI
B-09342395002223
Version Date
January 27, 2023
Manufacturer Last Update
May 24, 2021
Active Status
Yes
Manufacturer
Manufacturer Name
Ellex Medical Pty Ltd
Country
Australia
Country Type
NON_EU
Address
3-4 Second Avenue Mawson Lakes
Email
rpillay@ellex.com
Authorized Representative
SRN
IE-AR-000003995
Country
Ireland
Address
5 Fitzwilliam Square East Dublin
Email
info@ecrep.ie
Telephone
+353 89 225 1951
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:2022-12-15~2023-01-27
Device Characteristics
Human Tissues
No
Animal Tissues
No