Biopax
by Xuzhou Yongkang Electronic Science Technology Co., Ltd.
Ref YK-81C
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 | Number69217452FPO2V 06921745206134 | Date19 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- Withdrawn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/MDR Active
Specification
- Device Name
- Fingertip Pulse Oximeter
- Model / Reference
- YK-81C
- Primary DI / UDI-DI
- 06921745206134
- Basic UDI-DI
- 69217452FPO2V
- Direct Marketing DI
- 06921745206134
- EMDN Code
- Z1203020408 Pulse oximeters
- Device Class
- Class IIa
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000018890
- Authorised representative
- Prolinx GmbH DE-AR-000005129
Other devices from Xuzhou Yongkang Electronic Science Technology Co., Ltd
See all devices from Xuzhou Yongkang Electronic Science 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