Pulse Oximeter
by Shenzhen Viatom Technology Co., Ltd. 28 variants
Ref PO6CModel PO6B、PO6C
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-06934440102465 06934440102465 | Date21 Dec 2023 | 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- Withdrawn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
- Trade Name
- Wellue
- Device Name
- Pulse Oximeter
- Model / Reference
- PO6C, PO6B、PO6C
- Primary DI / UDI-DI
- 06934440102465
- Basic UDI-DI
- B-06934440102465, 69344401PO6BRJ
- Direct Marketing DI
- 06934440102465
- EMDN Code
- Z1203020408 Pulse oximeters
- Device Class
- Class IIa
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000012182
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
Other devices from Viatom 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