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EUDAMED registration 00816722021625Yes

enlighten SR

Cutera, Inc.Class IIbEU EUDAMEDTrade name: enlighten SR
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class IIb
CND nomenclatures code
Z12011019
Trade name
enlighten SR
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
00816722021625
Basic UDI
B-00816722021625
Active status
Yes
Manufacturer
Manufacturer name
Cutera, Inc.
Country
United States
Country type
NON_EU
Address
3240 Bayshore Blvd Brisbane
Email
info@cutera.com
Authorized representative
Name
MDSS GmbH
SRN
DE-AR-000005430
Country
Germany
Address
41 Schiffgraben Hannover
Email
info@mdssar.com
Regulatory information
Competent authority
DE/CA09 - Staatliches Gewerbeaufsichtsamt Hannover
Applicable legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed on the market
France
Market available
Belgium:2018-05-01~None, Bulgaria:2018-05-01~None, France:2018-05-01~None, Germany:2018-05-01~None, Italy:2018-05-01~None, Latvia:2018-05-01~None, Poland:2018-05-01~None, Slovakia:2018-05-01~None, Spain:2018-05-01~None, Sweden:2018-05-01~None
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

MULTI–PLATFORM LASER

About this record

Access comprehensive regulatory information for enlighten SR 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 00816722021625 and manufactured by Cutera, Inc. in United States.

This page provides complete registration details including trade name (enlighten SR), manufacturer information, authorized representative details, competent authority (DE/CA09 - Staatliches Gewerbeaufsichtsamt Hannover), 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.