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EUDAMED registration 06972820960632Yes

SPO2 Sensor

Shenzhen SINO-K Medical Technology Co., Ltd.Class IIbEU EUDAMEDTrade name: SP5325A
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class IIb
CND nomenclatures code
C900301
Trade name
SP5325A
Implantable
No
Reusable
Yes
Measuring function
Yes
Registration information
Primary DI
06972820960632
Basic UDI
B-06972820960632
Version date
October 11, 2023
Manufacturer last update
March 08, 2022
Active status
Yes
Manufacturer
Manufacturer name
Shenzhen SINO-K Medical Technology Co., Ltd.
Country
China
Country type
NON_EU
Address
Room 401, Bldg 2, Veteran Ind. City, Gongle Community, Xixiang Street, Baoan District Shenzhen
Email
huaweiyin@sino-k.com
Authorized representative
Name
Prolinx GmbH
SRN
DE-AR-000005129
Country
Germany
Address
56 Brehmstr Düsseldorf
Email
med@eulinx.eu
Telephone
+4921131054698
Regulatory information
Competent authority
DE/CA20, Bezirksregierung Düsseldorf Dezernat 24
Applicable legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed on the market
Ireland
Market available
Ireland:2019-06-25~2024-05-26
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

PULSE OXIMETER SENSORS

About this record

Access comprehensive regulatory information for SPO2 Sensor in the European Union medical device market through Pure Global AI's free database. This Class IIb device is registered with EU EUDAMED under Primary DI 06972820960632 and manufactured by Shenzhen SINO-K Medical Technology Co., Ltd. in China.

This page provides complete registration details including trade name (SP5325A), manufacturer information, authorized representative details, competent authority (DE/CA20, Bezirksregierung Düsseldorf Dezernat 24), 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.