EUDAMED registration 06975124100438Yes

Bladder Scanner

Name: Bladder Scanner — EUDAMED registration 06975124100438
Creator: SUZHOU PEAKSONIC MEDICAL TECHNOLOGY CO.,LTD.
Keywords: Bladder Scanner, 06975124100438, Bladder Scanner, Class IIa, SUZHOU PEAKSONIC MEDICAL TECHNOLOGY CO.,LTD., EUDAMED registration

SUZHOU PEAKSONIC MEDICAL TECHNOLOGY CO.,LTD.Class IIaEU EUDAMEDTrade name: Bladder Scanner

VerifiedEUDAMED · official EU database

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: 06975124100438
Basic UDI: 697512410M3WX
Active status: Yes

Manufacturer

Manufacturer name: SUZHOU PEAKSONIC MEDICAL TECHNOLOGY CO.,LTD.
Country: China
Country type: NON_EU
Address: 2A,West Side Of Building G4 Kunshan Hi-Tech Medical Device Industrial Park,Qiandeng Town Kunshan, Suzhou, Jiangsu
Email: vicky.yao@peaksonic.com.cn

Authorized representative

Name: Kingsmead Service B.V.
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

Device description (EMDN)

ULTRASONIC BLADDER VOLUME SCANNERS

About this record

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 06975124100438 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.