Elektrody EKG
by SORIMEX Sp. z o.o. 20 variants
Ref EK-S 50 NWSGModel EK-S
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number5903002221125B 05903002213049 | Date11 Jan 2024 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Disposable ECG electrodes
- Model / Reference
- EK-S, EK-S 50 NWSG
- Primary DI / UDI-DI
- 05903002213049
- Basic UDI-DI
- 5903002221125B
- EMDN Code
- C020501 ECG electrodes
- Device Class
- Class I
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- PL-MF-000020958
Other devices from SORIMEX Sp. z o.o.
Properties
Other properties (13)
- 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
- Measuring Function: No
- Incorporates Medicinal Product: No