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EUDAMED registration 00810007532400Yes

HydraFacial Syndeo

HydraFacial, LLCClass IIaEU EUDAMED
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class IIa
CND nomenclatures code
V9099
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
00810007532400
Basic UDI
B-00810007532400
Version date
March 29, 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
Name
ECREP LIMITED
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:2023-03-29~None
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER

About this record

Access comprehensive regulatory information for HydraFacial Syndeo in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI 00810007532400 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.