EUDAMED registration 06932562300622Yes

SpO2 sensor

Name: SpO2 sensor — EUDAMED registration 06932562300622
Creator: Guangdong Biolight Meditech Co., Ltd
Keywords: SpO2 sensor, 06932562300622, SpO2 Sensor , Class IIb, Guangdong Biolight Meditech Co., Ltd, EUDAMED registration

Guangdong Biolight Meditech Co., LtdClass IIbEU EUDAMEDTrade name: SpO2 Sensor

VerifiedEUDAMED · official EU database

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: 06932562300622
Basic UDI: 69325623500055D
Active status: Yes

Manufacturer

Manufacturer name: Guangdong Biolight Meditech Co., Ltd
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

Name: Shanghai International Holding Corp. GmbH(Europe)
SRN: DE-AR-000000001
Country: Germany
Address: 80 Eiffestraße 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

Device description (EMDN)

MULTI-PARAMETER MONITORS - CONSUMABLES

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 06932562300622 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.