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VeinLite PEDI2 - EUDAMED Registration 00195893253494

Access comprehensive regulatory information for VeinLite PEDI2 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 00195893253494 and manufactured by Translite, LLC in United States.

This page provides complete registration details including trade name (Veinlite PEDI2), 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.

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EUDAMED Official Data
Class I
00195893253494
No
VeinLite PEDI2
Trade Name: Veinlite PEDI2
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Device Description (EMDN)

TRANSILLUMINATORS

Device Classification
Risk Class
Class I
CND Nomenclatures Code
W0202030202
Trade Name
Veinlite PEDI2
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00195893253494
Basic UDI
B-00195893253494
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
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