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EUDAMED registration 00810049430139No

Theratogs Clinical Starter System

Theratogs IncClass IEU EUDAMEDTrade name: TheraTogs
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class I
CND nomenclatures code
Y060309
Trade name
TheraTogs
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
00810049430139
Basic UDI
8100494GCSSXY
Version date
February 16, 2023
Manufacturer last update
February 15, 2021
Active status
No
Manufacturer
Manufacturer name
Theratogs Inc
Country
United States
Country type
NON_EU
Address
305 Society Dr Telluride
Email
globalsales@theratogs.com
Authorized representative
Name
MedEnvoy Global BV
SRN
NL-AR-000024028
Country
Netherlands
Address
33 Prinses Margrietplantsoen The Hague
Email
EU-AR@medenvoyglobal.com
Telephone
+31 70 326 21 48
Regulatory information
Competent authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed on the market
Netherlands
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

THORACOLUMBOSACRAL SPINE ORTHOSES

About this record

Access comprehensive regulatory information for Theratogs Clinical Starter System 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 00810049430139 and manufactured by Theratogs Inc in United States.

This page provides complete registration details including trade name (TheraTogs), manufacturer information, authorized representative details, competent authority (Ministerie van Volksgezondheid, Welzijn en Sport), 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.