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FlexiOH - Light Cured Polymer Immobilizer - EUDAMED Registration 89080147650020

Access comprehensive regulatory information for FlexiOH - Light Cured Polymer Immobilizer 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 89080147650020 and manufactured by JC ORTHOHEAL PRIVATE LIMITED in India.

This page provides complete registration details including trade name (FlexiOH), manufacturer information, authorized representative details, competent authority (Agencia Espaรฑola de Medicamentos y Productos Sanitarios), 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
89080147650020
No
FlexiOH - Light Cured Polymer Immobilizer
Trade Name: FlexiOH
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Device Description (EMDN)

IMMOBILISATION SYSTEMS AND DEVICES - OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
M030599
Trade Name
FlexiOH
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
89080147650020
Basic UDI
8908014765FLXFY
Version Date
December 26, 2022
Manufacturer Last Update
April 18, 2023
Active Status
No
Manufacturer
Country
India
Country Type
NON_EU
Address
Old Padra Road Vadodara
Email
contact@orthoheal.com
Authorized Representative
SRN
ES-AR-000018076
Country
Spain
Address
281 Muntaner Barcelona
Email
info@afpharmaservice.com
Regulatory Information
Competent Authority
Agencia Espaรฑola de Medicamentos y Productos Sanitarios
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Italy
Device Characteristics
Human Tissues
No
Animal Tissues
No