Pure Global
04719890063809

UPPER EXTREMITY ORTHOSES

Welsheng Corp.·Class I·EU EUDAMED·Trade name: Wrist/Forearm BraceNo
Device classification
Risk class
Class I
CND nomenclatures code
Y060699
Trade name
Wrist/Forearm Brace
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
04719890063809
Basic UDI
471988489CL103GL
Active status
No
Manufacturer
Manufacturer name
Welsheng Corp.
Country
Taiwan
Country type
NON_EU
Address
9F, No. 295, Sec. 4, Chung Hsiao East Rd. Taipei
Email
katehong@lp-support.com
Authorized representative
Name
Medical Technology Promedt Consulting GmbH
SRN
DE-AR-000000085
Country
Germany
Address
7 Ernst-Heckel-Straße St. Ingbert
Email
ear@mt-procons.com
Telephone
+49 6894 581020
Regulatory information
Competent authority
DE/CA70 - Landesamt für Umwelt- und Arbeitsschutz
Applicable legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed on the market
Malta
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

ORTHOSES, UPPER EXTREMITY - OTHER

About this record

Access comprehensive regulatory information for UPPER EXTREMITY ORTHOSES 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 04719890063809 and manufactured by Welsheng Corp. in Taiwan.

This page provides complete registration details including trade name (Wrist/Forearm Brace), manufacturer information, authorized representative details, competent authority (DE/CA70 - Landesamt für Umwelt- und Arbeitsschutz), 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.