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Comen Star5000
EUDAMEDClass I (EU MDR)
Ref SK-COM-15190-150RSModel SKYMEDRef SK-COM15190-150RSRef APP-COM15190-150RSModel ALPHA-PLUS
Identity
- Trade Name
- COMEN STAR5000 EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-COM-15190-150RS EUDAMEDSK-COM15190-150RS EUDAMEDALPHA-PLUS EUDAMEDAPP-COM15190-150RS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019810513 EUDAMED09551019819134 EUDAMED
- Basic UDI-DI
- 955101981MCRP-SMPY EUDAMED955101981MCRPAPH3 EUDAMED
- Direct Marketing DI
- 09551019810513 EUDAMED09551019819134 EUDAMED
- EMDN Code
- Z12059009 ECG DATA MANAGEMENT SYSTEMS EUDAMED
Classification
- Device Class
- Class I EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Comen Star5000 by Isd Meditech Sdn. Bhd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 955101981MCRP-SMPY | Class I | Active |
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Manufacturer
- Manufacturer
- Isd Meditech Sdn. Bhd.
- EUDAMED SRN
- MY-MF-000043531
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED fbda0a8d-457e-4d34-b1e9-7c722ee8a514 61 fields · synced Jul 9, 2026
- EUDAMED b590840e-cfea-48f6-8899-322871b46875 61 fields · synced Jun 20, 2026
- EUDAMED cefdd13c-81b4-410f-9943-a3b8ffb854b9 61 fields · synced Jul 9, 2026