Finger Clip Pulse Oximeter
by Guangdong Genial Technology CO., LTD 7 variants
Ref GX11, GX8, GX4, GX10, GX7, GX9
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 | Number69368270GXHG | Date9 Mar 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- Withdrawn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
- Model / Reference
- GX11, GX8, GX4, GX10, GX7, GX9
- Primary DI / UDI-DI
- 06936827001699, 06936827002900, 06936827002832, 06936827002948, 06936827002887, 06936827002924
- Basic UDI-DI
- 69368270GXHG
- Direct Marketing DI
- 069368270016990693682700290006936827002832069368270029480693682700288706936827002924
- EMDN Code
- Z1203020408 Pulse oximeters
- Device Class
- Class IIa
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000021465
- Authorised representative
- MedPath GmbH DE-AR-000000087
Other devices from Guangdong Genial 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