SpO2 sensor
by Shenzhen Ykd Technology Co., Ltd. 10 variants
Ref CSL066D
Active
CE MDD
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/MDD | NumberB-06975319831765 06975319831765 | Date26 Dec 2024 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Model / Reference
- CSL066D
- Primary DI / UDI-DI
- 06975319831765
- Basic UDI-DI
- B-06975319831765
- EMDN Code
- C900301 Pulse oximeter sensors
- Device Class
- Class IIb
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000017263
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Shenzhen Ykd Technology Co., Ltd.
Properties
Other properties (10)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Incorporates Medicinal Product: No