Pure Global

ORTHOSES, UPPER EXTREMITY - EUDAMED Registration 04711769157251

Access comprehensive regulatory information for ORTHOSES, UPPER EXTREMITY 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 04711769157251 and manufactured by OPPO Medical Corp. in Taiwan.

This page provides complete registration details including trade name (Shoulder Activator), manufacturer information, authorized representative details, competent authority (DE/CA70 - Landesamt fรผr 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.

Free Database
Powered by Pure Global AI
EUDAMED Official Data
Class I
04711769157251
No
ORTHOSES, UPPER EXTREMITY
Trade Name: Shoulder Activator
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Description (EMDN)

ORTHOSES, UPPER EXTREMITY - OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Y060699
Trade Name
Shoulder Activator
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
04711769157251
Basic UDI
471986369CL103DH
Version Date
December 10, 2024
Manufacturer Last Update
May 26, 2021
Active Status
No
Manufacturer
Manufacturer Name
OPPO Medical Corp.
Country
Taiwan
Country Type
NON_EU
Address
9F, No. 297, Sec. 4, Chung Hsiao East Rd. Taipei
Email
peggylin@oppomedical.com
Authorized Representative
SRN
DE-AR-000000085
Country
Germany
Address
7 Ernst-Heckel-StraรŸe St. Ingbert
Email
ear@mt-procons.com
Telephone
+49 6894 581020
Regulatory Information
Competent Authority
DE/CA70 - Landesamt fรผr Umwelt- und Arbeitsschutz
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Ireland
Device Characteristics
Human Tissues
No
Animal Tissues
No