SpO2 sensor
by Shenzhen Redy-Med Technology Co., Ltd 9 variants
Ref S2PF30-001Model S2AF30-001,S2AF11-149,S2AF11-101,S2PF30-001,S2AS30-001,S2PS30-001 and S2NG30-001
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number6976725851845HE 06976725850142 | Date23 Aug 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- SpO2 sensor
- Model / Reference
- S2AF30-001,S2AF11-149,S2AF11-101,S2PF30-001,S2AS30-001,S2PS30-001 and S2NG30-001, S2PF30-001
- Primary DI / UDI-DI
- 06976725850142
- Basic UDI-DI
- 6976725851845HE
- Direct Marketing DI
- 06976725850142
- EMDN Code
- C900301 Pulse oximeter sensors
- Device Class
- Class IIb
- EU market of registration
- Portugal
Manufacturer details
- EUDAMED SRN
- CN-MF-000029812
- Authorised representative
- Umedwings Netherlands B.V. NL-AR-000000444
From the manufacturer
Manufacturer's product page: Spo2
Other devices from Shenzhen Redy-Med Technology Co., Ltd
See all devices from Shenzhen Redy-Med Technology Co., Ltd →
Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Incorporates Medicinal Product: No