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EUDAMED registration 00195893277230No

VLEDX-DPC Card

Translite, LLCClass IEU EUDAMEDTrade name: Veinlite LEDX DPC Card
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class I
CND nomenclatures code
T030199
Trade name
Veinlite LEDX DPC Card
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
00195893277230
Basic UDI
B-00195893277230
Version date
October 06, 2023
Manufacturer last update
October 07, 2022
Active status
No
Manufacturer
Manufacturer name
Translite, LLC
Country
United States
Country type
NON_EU
Address
345 Commerce Green Blvd Sugar Land, Texas
Email
info@veinlite.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
Ireland
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

COVERS, INSTRUMENTS AND EQUIPMENT - OTHER

About this record

Access comprehensive regulatory information for VLEDX-DPC Card 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 00195893277230 and manufactured by Translite, LLC in United States.

This page provides complete registration details including trade name (Veinlite LEDX DPC Card), 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.