Pure Global

Bladder Scanner - EUDAMED Registration 06975124100148

Access comprehensive regulatory information for Bladder Scanner 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 06975124100148 and manufactured by SUZHOU PEAKSONIC MEDICAL TECHNOLOGY CO.,LTD. in China.

This page provides complete registration details including trade name (Bladder Scanner), manufacturer information, authorized representative details, competent authority (Ministerie van Volksgezondheid, Welzijn en Sport), 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
06975124100148
Yes
Bladder Scanner
Trade Name: Bladder Scanner
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Description (EMDN)

ULTRASONIC BLADDER VOLUME SCANNERS

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Z12080304
Trade Name
Bladder Scanner
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06975124100148
Basic UDI
697512410M1WT
Active Status
Yes
Manufacturer
Country
China
Country Type
NON_EU
Address
2A,Westย Sideย Ofย Buildingย G4 Kunshanย Hi-Techย Medicalย Deviceย Industrialย Park,Qiandengย Town Kunshan, Suzhou, Jiangsu
Email
vicky.yao@peaksonic.com.cn
Authorized Representative
SRN
NL-AR-000002066
Country
Netherlands
Address
Zonnehof 36 Nootdorp
Email
office@kingsmead-service.com
Telephone
+31(0) 64 6571 005
Regulatory Information
Competent Authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
France
Market Available
Denmark:None~None, France:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No