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Blood Pressure Monitor - EUDAMED Registration 06948158400294

Access comprehensive regulatory information for 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 06948158400294 and manufactured by Shenzhen Combei Technology Co.,Ltd. in China.

This page provides complete registration details including trade name (Pempa), manufacturer information, authorized representative details, competent authority (DE/CA22 - Bezirksregierung Münster), 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.

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EUDAMED Official Data
Class IIa
06948158400294
Yes
Blood Pressure Monitor
Trade Name: Pempa
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Device Description (EMDN)

NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Z1203020501
Trade Name
Pempa
Implantable
No
Reusable
No
Measuring Function
Yes
Registration Information
Primary DI
06948158400294
Basic UDI
69481584ARM03T6
Active Status
Yes
Manufacturer
Country
China
Country Type
NON_EU
Address
11-5B,No.105,Huanguan South Road,Dahe Community,Guanhu Street,Longhua District shenzhen,Guangdong
Email
kevin.fong@combei.cn
Authorized Representative
SRN
DE-AR-000000002
Country
Germany
Address
10 Borkstrasse Münster
Email
ecrep@medneteurope.com
Telephone
+49 251 322 66 64
Regulatory Information
Competent Authority
DE/CA22 - Bezirksregierung Münster
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Poland
Market Available
Poland:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No