Pure Global

Wrist Electronic Sphygmomanometer - EUDAMED Registration 06951727602579

Access comprehensive regulatory information for Wrist Electronic Sphygmomanometer 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 06951727602579 and manufactured by Shenzhen Changkun Technology Co., Ltd. in China.

This page provides complete registration details including trade name (CHANGKUN), manufacturer information, authorized representative details, competent authority (DE/CA304 - Marktรผberwachung Medizinprodukte Bayern), 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 IIa
06951727602579
Yes
Wrist Electronic Sphygmomanometer
Trade Name: CHANGKUN
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Description (EMDN)

NONโ€“INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Z1203020501
Trade Name
CHANGKUN
Implantable
No
Reusable
Yes
Measuring Function
Yes
Registration Information
Primary DI
06951727602579
Basic UDI
B-06951727602579
Version Date
April 18, 2024
Manufacturer Last Update
May 31, 2022
Active Status
Yes
Manufacturer
Country
China
Country Type
NON_EU
Address
Room 501, Changkun Technology Building A, 12 Shijia Road, Biling Community, Biling Subdistrict, Pingshan District Shenzhen City, Guangdong Province
Email
2753749309@qq.com
Authorized Representative
SRN
DE-AR-000005133
Country
Germany
Address
83 Heerdter Lohweg Dรผsseldorf
Email
eu-rep@share-info.com
Regulatory Information
Competent Authority
DE/CA304 - Marktรผberwachung Medizinprodukte Bayern
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Germany
Market Available
Germany:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No