Pure Global AI
EUDAMED registration 06972040110442Yes

Pulse Oximeter

Shenzhen AOJ Medical Technology Co., Ltd.Class IIaEU EUDAMEDTrade name: Pulse Oximeter
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class IIa
CND nomenclatures code
Z1203020408
Trade name
Pulse Oximeter
Implantable
No
Reusable
No
Measuring function
Yes
Registration information
Primary DI
06972040110442
Basic UDI
697204011AOJ70X18B
Version date
February 06, 2025
Manufacturer last update
August 01, 2022
Active status
Yes
Manufacturer
Manufacturer name
Shenzhen AOJ Medical Technology Co., Ltd.
Country
China
Country type
NON_EU
Address
Shenzhen
Email
regulation@aojmedical.com
Authorized representative
Name
Share info GmbH
SRN
DE-AR-000005132
Country
Germany
Address
12 Am Schulzentrum Kaarst
Email
eu-rep@share-info.com
Telephone
+49 01795666508
Regulatory information
Competent authority
DE/CA20, Bezirksregierung Düsseldorf Dezernat 24
Applicable legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed on the market
Germany
Market available
Bulgaria:2024-03-09~2026-03-08, Croatia:2024-03-09~2026-03-08, Czechia:2024-03-09~2026-03-08, France:2024-03-09~2026-03-08, Germany:2024-03-09~2026-03-08, Hungary:2024-03-09~2026-03-08, Italy:2024-03-09~2026-03-08, Netherlands:2024-03-09~2026-03-08, Poland:2024-03-09~2026-03-08, Portugal:2024-03-09~2026-03-08, Romania:2024-03-09~2026-03-08, Slovakia:2024-03-09~2026-03-08, Spain:2024-03-09~2026-03-08
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

PULSE OXIMETERS

About this record

Access comprehensive regulatory information for Pulse Oximeter 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 06972040110442 and manufactured by Shenzhen AOJ Medical Technology Co., Ltd. in China.

This page provides complete registration details including trade name (Pulse Oximeter), 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.