Spo2 sensor
Ref SS-026XC-PF30
Spo2 sensor (SS-026XC-PF30) is a Class IIb device made by Orantech Inc., registered in EUDAMED on 9 May 2024 (Basic UDI-DI B-06941691913955), active as of 25 Oct 2026.
Active
CE MDD
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-06941691913955 06941691913955 | Date9 May 2024 | StatusActive |
Official records
- EUDAMED public site B-06941691913955
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Model / reference
- SS-026XC-PF30
- Primary DI / UDI-DI
- 06941691913955
- Basic UDI-DI
- B-06941691913955
- EMDN code
- C900301 Pulse oximeter sensors
- Device class
- Class IIb
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Denmark
Manufacturer details
- EUDAMED SRN
- CN-MF-000013859
- Authorised representative
- Medten EU ApS DK-AR-000034434
Similar devices in this category
Other devices filed under PULSE OXIMETER SENSORS.
- RUI RSA002DN-M200 by Beijing Rongrui-Century Science & Technology Co., Ltd.
- 8000R Reusable Reflectance Pulse Oximetry Sensor 114240-001 by Nonin Medical, Inc.
- SP1119 07-10-00 by Shenzhen SINO-K Medical Technology Co., Ltd
- 8000Q2 Reusable Ear Clip Pulse Oximetry Sensor 114239-001 by Nonin Medical, Inc.
- LNCS-II rainbow 4067 by MASIMO CORPORATION
- RUI RSA066DN-P100 by Beijing Rongrui-Century Science & Technology Co., Ltd.
- Reusable Oximeter Probes WP-10387 by Shenzhen Envisen Industry Co., Ltd.
- RD rainbow 4034 by MASIMO CORPORATION
- SpO2 sensor S2AF11-149 by Shenzhen Redy-Med Technology Co.,Ltd
- Reusable Soft SpO2 Sensor FMT-RAS(B)/CHC-LR by METKO MEDİKAL VE TIBBİ CİHAZLAR DIŞ TİCARET SANAYİ ANONİM ŞİRKETİ