Reusable SpO2 Sensor
by APK Technology Co., Ltd. 194 variants
Part of a family of 603 devices: see the family page
Ref A2004-SA191PV
Reusable SpO2 Sensor (A2004-SA191PV) is a Class IIb device made by APK Technology Co., Ltd., registered in EUDAMED on 10 Jun 2026 (Basic UDI-DI 69467255A-SPO2-RUV), active as of 24 Oct 2026.
Active
CE MDR
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/MDR | Number69467255A-SPO2-RUV 06946725549063 | Date10 Jun 2026 | StatusActive |
Official records
- EUDAMED public site 69467255A-SPO2-RUV
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / reference
- A2004-SA191PV
- Primary DI / UDI-DI
- 06946725549063
- Basic UDI-DI
- 69467255A-SPO2-RUV
- EMDN code
- C900301 Pulse oximeter sensors
- Device class
- Class IIb
- EU registration type
- Standard device
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000011581
- Authorised representative
- Ruiyi Healthcare GmbH DE-AR-000005962
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