Spo2 sensor
- Risk class
- Class IIb
- CND nomenclatures code
- C900301
- Trade name
- Spo2 sensor
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 06941691927518
- Basic UDI
- B-06941691927518
- Version date
- February 05, 2025
- Manufacturer last update
- September 29, 2021
- Active status
- Yes
- Manufacturer name
- Orantech Inc.
- Country
- China
- Country type
- NON_EU
- Address
- GongMing Shenzhen
- affairs@orantech.com
- Name
- Medten EU ApS
- SRN
- DK-AR-000034434
- Country
- Denmark
- Address
- 33 Oldenvej Kvistgård
- eu@medten.com
- Telephone
- +45 53 65 30 77
- Competent authority
- Ministerie van Volksgezondheid, Welzijn en Sport
- Applicable legislation
- MDD (Directive 93/42/EEC on Medical Devices)
- Placed on the market
- Denmark
- Market available
- Denmark:None~None, France:None~None, Germany:None~None, Netherlands:None~None, Poland:None~None
- Human tissues
- No
- Animal tissues
- No
PULSE OXIMETER SENSORS
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 06941691927518 and manufactured by Orantech Inc. in China.
This page provides complete registration details including trade name (Spo2 sensor), manufacturer information, authorized representative details, competent authority (Ministerie van Volksgezondheid, Welzijn en Sport), 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.