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Spo2 sensor - EUDAMED Registration 06941691927525

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 06941691927525 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.

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EUDAMED Official Data
Class IIb
06941691927525
Yes
Spo2 sensor
Trade Name: Spo2 sensor
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Device Description (EMDN)

PULSE OXIMETER SENSORS

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
C900301
Trade Name
Spo2 sensor
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06941691927525
Basic UDI
B-06941691927525
Version Date
February 05, 2025
Manufacturer Last Update
September 29, 2021
Active Status
Yes
Manufacturer
Manufacturer Name
Orantech Inc.
Country
China
Country Type
NON_EU
Address
GongMing Shenzhen
Email
affairs@orantech.com
Authorized Representative
SRN
DK-AR-000034434
Country
Denmark
Address
33 Oldenvej Kvistgรฅrd
Email
eu@medten.com
Telephone
+45 53 65 30 77
Regulatory Information
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
Device Characteristics
Human Tissues
No
Animal Tissues
No