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EUDAMED registration 08559970065554No

Lumio

DermLite LLCClass IEU EUDAMEDTrade name: DERMLITE
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class I
CND nomenclatures code
Z12040108
Trade name
DERMLITE
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
08559970065554
Basic UDI
085599700655585
Version date
August 26, 2024
Manufacturer last update
June 09, 2023
Active status
No
Manufacturer
Manufacturer name
DermLite LLC
Country
United States
Country type
NON_EU
Address
21 Argonaut Aliso Viejo CA
Email
info@ecrep.ie
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
Germany
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

DERMATOSCOPES

About this record

Access comprehensive regulatory information for Lumio 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 08559970065554 and manufactured by DermLite LLC in United States.

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