Pure Global AI
EUDAMED registration 06953825908904Yes

Upper Arm Electronic Blood Pressure Monitor

Shenzhen Urion Technology Co., Ltd.Class IIaEU EUDAMEDTrade name: depan
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class IIa
CND nomenclatures code
Z1203020501
Trade name
depan
Implantable
No
Reusable
No
Measuring function
Yes
Registration information
Primary DI
06953825908904
Basic UDI
B-06953825908904
Active status
Yes
Manufacturer
Country
China
Country type
NON_EU
Address
No.3 Floor 4-6th of Building D, Jiale Science&Technology Industrial Zone, No.3, ChuangWei Road, Heshuikou Community, MaTian Street, GuangMing New District Shenzhen
Email
urion@urion.com.cn
Authorized representative
SRN
XI-AR-000001836
Country
United Kingdom (Northern Ireland only)
Address
Enterprise Hub, NW Business Complex, Derry
Email
AuthRep@CE-marking.eu
Telephone
+44(33)33031126
Regulatory information
Competent authority
DE/CA05 - Behorde fur Justiz und Verbraucherschutz
Applicable legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed on the market
United Kingdom (Northern Ireland only)
Market available
United Kingdom (Northern Ireland only):2024-10-31~2028-12-31
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES

About this record

Access comprehensive regulatory information for Upper Arm Electronic Blood Pressure Monitor in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI 06953825908904 and manufactured by Shenzhen Urion Technology Co., Ltd. in China.

This page provides complete registration details including trade name (depan), manufacturer information, authorized representative details, competent authority (DE/CA05 - Behorde fur Justiz und Verbraucherschutz), 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.