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EUDAMED registration 04719961660852No

Shoulder Support/ Shoulder Brace/Shoulder Wrap

Irufa Industrial Group CO., LTD.Class IEU EUDAMEDTrade name: Shoulder Support/ Shoulder Brace/Shoulder Wrap
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class I
CND nomenclatures code
Y060621
Trade name
Shoulder Support/ Shoulder Brace/Shoulder Wrap
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
04719961660852
Basic UDI
471996166SHOULDERR5
Version date
February 21, 2025
Manufacturer last update
February 17, 2025
Active status
No
Manufacturer
Manufacturer name
Irufa Industrial Group CO., LTD.
Country
Taiwan
Country type
NON_EU
Address
No 32, Alley 182, Cheng-Ping 7th St. Tainan
Email
aroha@irufa.com
Authorized representative
Name
KHANG BAO INTERNATIONAL KFT
SRN
HU-AR-000034102
Country
Hungary
Address
13. al. 1 Budapest, Auróra utca BUDAPEST
Email
eudamed.representative@gmail.com
Telephone
+36706790786
Regulatory information
Competent authority
Nemzeti Népegészségügyi és Gyógyszerészeti Központ
Applicable legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed on the market
Finland
Market available
Belgium:None~None, Czechia:None~None, Finland:None~None, France:None~None, Germany:None~None, Hungary:None~None, Ireland:None~None, Italy:None~None, Poland:None~None, Spain:None~None, Türkiye:None~None, United Kingdom (Northern Ireland only):None~None
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

SHOULDER ORTHOSES

About this record

Access comprehensive regulatory information for Shoulder Support/ Shoulder Brace/Shoulder Wrap 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 04719961660852 and manufactured by Irufa Industrial Group CO., LTD. in Taiwan.

This page provides complete registration details including trade name (Shoulder Support/ Shoulder Brace/Shoulder Wrap), manufacturer information, authorized representative details, competent authority (Nemzeti Népegészségügyi és Gyógyszerészeti Központ ), 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.