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THERMOPLASTIC SPLINT - EUDAMED Registration 138800211USA800025

Access comprehensive regulatory information for THERMOPLASTIC SPLINT 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 138800211USA800025 and manufactured by WOOSAM MEDICAL CO., LTD. in Republic of Korea.

This page provides complete registration details including manufacturer information, authorized representative details, competent authority (Agencia Española 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
138800211USA800025
No
THERMOPLASTIC SPLINT
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

ORTHOSES, UPPER EXTREMITY - OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Y060699
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
138800211USA800025
Basic UDI
88002111EUTHLJ
Version Date
November 27, 2024
Manufacturer Last Update
November 22, 2024
Active Status
No
Manufacturer
Manufacturer Name
WOOSAM MEDICAL CO., LTD.
Country
Republic of Korea
Country Type
NON_EU
Address
89-25, Tongil-ro 642beon-gil, Wollong-myeon, Paju-si, Gyeonggi-do
Email
woosam0781@gmail.com
Authorized Representative
SRN
ES-AR-000018076
Country
Spain
Address
281 Muntaner Barcelona
Email
info@afpharmaservice.com
Regulatory Information
Competent Authority
Agencia Española de Medicamentos y Productos Sanitarios
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Finland
Device Characteristics
Human Tissues
No
Animal Tissues
No