Central Monitoring System
by Shenzhen Creative Industry Co., Ltd. 2 variants
Ref AI-ECG MonitorModel AI-ECG Monitor、PC-1000A
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 | Number69419006CMSPM0101DU 06941900602519 | Date21 Apr 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- Withdrawn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
- Central Monitoring System
- Model / Reference
- AI-ECG Monitor、PC-1000A, AI-ECG Monitor
- Primary DI / UDI-DI
- 06941900602519
- Basic UDI-DI
- 69419006CMSPM0101DU
- EMDN Code
- Z1203020292 Multi-parameter monitors - medical device software
- Device Class
- Class IIb
- Special Device Type
- Software
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000009430
- Authorised representative
- Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551
Other devices from Shenzhen Creative Industry Co., Ltd.
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