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Hydrafacial Syndeo™ Black Handpiece - EUDAMED Registration 00810007532363

Access comprehensive regulatory information for Hydrafacial Syndeo™ Black Handpiece in the European Union medical device market through Pure Global AI's free database. This Class I device is registered with EU EUDAMED under Primary DI 00810007532363 and manufactured by HydraFacial, LLC in United States.

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 I
00810007532363
Yes
Hydrafacial Syndeo™ Black Handpiece
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
V9099
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00810007532363
Basic UDI
B-00810007532363
Version Date
March 24, 2023
Manufacturer Last Update
October 06, 2023
Active Status
Yes
Manufacturer
Manufacturer Name
HydraFacial, LLC
Country
United States
Country Type
NON_EU
Address
3600 E. Burnett Street Long Beach, CA
Email
regulatoryaffairs@hydrafacial.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
Device Characteristics
Human Tissues
No
Animal Tissues
No