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Comen Star5000c
EUDAMEDClass I (EU MDR)
Ref SK-COM-112100-150RModel SKYMEDRef SK-COM112100-150RRef APP-COM112100-150RModel ALPHA-PLUS
Identity
- Trade Name
- COMEN STAR5000C EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-COM-112100-150R EUDAMEDSK-COM112100-150R EUDAMEDALPHA-PLUS EUDAMEDAPP-COM112100-150R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019810506 EUDAMED09551019819127 EUDAMED
- Basic UDI-DI
- 955101981MCRP-SMPY EUDAMED955101981MCRPAPH3 EUDAMED
- Direct Marketing DI
- 09551019810506 EUDAMED09551019819127 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 Star5000c 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 3062cf6f-c6d0-4c12-946b-a309246ca1d7 61 fields · synced Oct 6, 2026
- EUDAMED b278d4f6-4514-471c-99e1-f44b3e46e3e9 61 fields · synced Jun 19, 2026
- EUDAMED d16ae7d5-7c31-4662-8fce-ad864df6b8dd 61 fields · synced Jul 24, 2026