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SpO2 sensor - EUDAMED Registration 06932562300660

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 06932562300660 and manufactured by Guangdong Biolight Meditech Co., Ltd in China.

This page provides complete registration details including trade name (SpO2 sensor), manufacturer information, authorized representative details, competent authority (DE/CA05 - Behorde fur Justiz und Verbraucherschutz), 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 IIb
06932562300660
Yes
SpO2 sensor
Trade Name: SpO2 sensor
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Device Description (EMDN)

MULTI-PARAMETER MONITORS - CONSUMABLES

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
Z1203020285
Trade Name
SpO2 sensor
Implantable
No
Reusable
No
Measuring Function
Yes
Registration Information
Primary DI
06932562300660
Basic UDI
69325623500055D
Active Status
Yes
Manufacturer
Country
China
Country Type
NON_EU
Address
No.2 No.2 Innovation First Road, Technical Innovation Coast, Hi-tech Zone, Zhuhai, P.R. China Zhuhai
Email
hou_d@blt.com.cn
Authorized Representative
SRN
DE-AR-000000001
Country
Germany
Address
80 EiffestraรŸe Hamburg
Email
shholding@hotmail.com
Telephone
+49 40 2513175
Regulatory Information
Competent Authority
DE/CA05 - Behorde fur Justiz und Verbraucherschutz
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Germany
Market Available
France:2024-09-20~2028-04-10, Germany:2024-09-20~2028-04-10, Poland:2024-09-20~2028-04-10
Device Characteristics
Human Tissues
No
Animal Tissues
No