Reusable SpO2 Sensors
by Xinkang Medical Instrument Co., Ltd. 16 variants
Ref XSAS2
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 | Number6974264560000000001NN 06974264560102 | Date8 Jun 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- Withdrawn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
- Reusable SpO2 Sensors
- Model / Reference
- XSAS2
- Primary DI / UDI-DI
- 06974264560102
- Basic UDI-DI
- 6974264560000000001NN
- EMDN Code
- C900301 Pulse oximeter sensors
- Device Class
- Class IIb
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000011906
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Xinkang Medical Instrument Co., Ltd.
Properties
Other properties (11)
- Sterile: No
- Implantable: 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