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Central Monitoring System
EUDAMEDClass IIb (EU MDR)
Ref PC-1000AModel AI-ECG Monitor、PC-1000A
Identity
- Device Name
- Central Monitoring System EUDAMED
- Model / Reference
- AI-ECG Monitor、PC-1000A EUDAMEDPC-1000A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941900602472 EUDAMED
- Basic UDI-DI
- 69419006CMSPM0101DU EUDAMED
- EMDN Code
- Z1203020292 MULTI-PARAMETER MONITORS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Netherlands 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
Central Monitoring System by Shenzhen Creative Industry 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 | 69419006CMSPM0101DU | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shenzhen Creative Industry Co., Ltd.
- EUDAMED SRN
- CN-MF-000009430
- Authorised Representative
- Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551
Sources (1)
- EUDAMED 946fc8f8-73af-4335-83a0-deb0e050773d 61 fields · synced Jun 11, 2026