ECG Roll (106mm x 20m)
by Isd Meditech Sdn. Bhd. EUDAMED
Active
Ref SK-10620/16RModel SKYMED
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number955101981MCRP-SMPY | Date7 Mar 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Medical Chart Recording Paper
- Model / Reference
- SKYMED, SK-10620/16R
- Primary DI / UDI-DI
- 09551019815808
- Basic UDI-DI
- 955101981MCRP-SMPY
- Direct Marketing DI
- 09551019815808
- EMDN Code
- Z12059009 ECG data management systems
- Device Class
- Class I
Manufacturer details
- EUDAMED SRN
- MY-MF-000043531
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from Isd Meditech Sdn. Bhd.
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