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EUDAMED registration 06975918771585No

Protective Gear

NANJING IHOME COMFORT CO.,LTDClass IEU EUDAMED
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class I
CND nomenclatures code
Y060306
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
06975918771585
Basic UDI
697591877PG16TR
Version date
January 10, 2024
Manufacturer last update
August 17, 2023
Active status
No
Manufacturer
Manufacturer name
NANJING IHOME COMFORT CO.,LTD
Country
China
Country type
NON_EU
Address
Shaohua Workshop, 89 Pingliang street, Jianye District Nanjing, Jiangsu
Email
sunchina88@126.com
Authorized representative
Name
Sungo Cert GmbH
SRN
DE-AR-000010869
Country
Germany
Address
47 Harffstr. Düsseldorf
Email
de.rep@sungoglobal.com
Regulatory information
Competent authority
DE/CA20, Bezirksregierung Düsseldorf Dezernat 24
Applicable legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed on the market
Austria
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

THORACOLUMBAR ORTHOSES

About this record

Access comprehensive regulatory information for Protective Gear 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 06975918771585 and manufactured by NANJING IHOME COMFORT CO.,LTD in China.

This page provides complete registration details including manufacturer information, authorized representative details, competent authority (DE/CA20, Bezirksregierung Düsseldorf Dezernat 24), 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.