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Central Monitoring System Software
EUDAMEDClass IIb (EU MDR)
Ref eCenter-CMSRef STAR8800Ref eCenter-OB
Identity
- Trade Name
- Central Monitoring System Software EUDAMEDCentral Monitoring System EUDAMED
- Device Name
- Central Monitoring System Software EUDAMEDCentral Monitoring System EUDAMED
- Model / Reference
- eCenter-CMS EUDAMEDSTAR8800 EUDAMEDeCenter-OB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429060744 EUDAMED06945429020694 EUDAMED06945429062373 EUDAMED
- Basic UDI-DI
- 69454290MS003PP EUDAMED69454290MS001PK EUDAMED69454290MS005PT EUDAMED
- Direct Marketing DI
- 06945429020694 EUDAMED06945429062373 EUDAMED
- EMDN Code
- Z12030292 VITAL SIGNS MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMEDZ1203020292 MULTI-PARAMETER MONITORS - MEDICAL DEVICE SOFTWARE EUDAMEDZ12030201 CENTRAL INFORMATION COMPUTING SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Finland EUDAMEDIceland 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Central Monitoring System Software by Shenzhen Comen Medical Instruments Co., LTD. — Class IIb — 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 | 69454290MS003PP | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shenzhen Comen Medical Instruments Co., LTD.
- EUDAMED SRN
- CN-MF-000002236
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (3)
- EUDAMED a185a3b7-fa0b-4451-a4e8-915c86ca2789 61 fields · synced Oct 6, 2026
- EUDAMED ccb2673d-0d91-4dc6-a7e8-aefa8de2a38b 61 fields · synced May 18, 2026
- EUDAMED 11fd7675-25db-4c3a-bd6c-c987aac3d9f9 61 fields · synced May 19, 2026