Fingertip Pulse Oximeter
by Shenzhen Bsx Technology Electronics Co., Ltd. 2 variants
Ref REFModel BSX253,BSX233,BSX251,BSX255B,BSX238B,BSX231
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 | Number69204853BSXQ3R7 06920485307514 | Date14 Nov 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- Withdrawn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
- BSX253, BSX233, BSX251, BSX255B, BSX238B, BSX231, REF
- Primary DI / UDI-DI
- 06920485307514
- Basic UDI-DI
- 69204853BSXQ3R7
- Direct Marketing DI
- 06920485307514
- EMDN Code
- Z1203020408 Pulse oximeters
- Device Class
- Class IIa
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000015965
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
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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