Schiller 2157-036
by Isd Meditech Sdn. Bhd. 3 variants
Ref APP-S210140-180RSModel ALPHA-PLUS
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 | Number955102627MCRPAPFF 09551026272366 | Date26 May 2026 | 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- Withdrawn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
- Medical chart Recording Paper
- Model / Reference
- ALPHA-PLUS, APP-S210140-180RS
- Primary DI / UDI-DI
- 09551026272366
- Basic UDI-DI
- 955102627MCRPAPFF
- Direct Marketing DI
- 09551026272366
- 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