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EUDAMED registration 00810007532127No

Elite Hydrafacial Lymphatic Kit

HydraFacial, LLCClass IEU EUDAMEDTrade name: HydraFacial
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class I
CND nomenclatures code
Z12040299
Trade name
HydraFacial
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
00810007532127
Basic UDI
008100075321276S
Version date
March 03, 2025
Manufacturer last update
February 25, 2025
Active status
No
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
Name
E C REP LIMITED
SRN
IE-AR-000003995
Country
Ireland
Address
5 Fitzwilliam Square East Dublin D2
Email
info@ecrep.ie
Telephone
+353 89 225 1951
Regulatory information
Competent authority
Health Products Regulatory Authority, Medical Devices Department
Applicable legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed on the market
France
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - OTHER

About this record

Access comprehensive regulatory information for Elite Hydrafacial Lymphatic Kit 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 00810007532127 and manufactured by HydraFacial, LLC in United States.

This page provides complete registration details including trade name (HydraFacial), 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.