Multi-parameter patient monitor
by Shenzhen Comen Medical Instruments Co., LTD. China EUDAMED
Ref C30AModel C30 EMDN Z1203020201
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberCN23/00001577 | Date14 Apr 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- CN23/00001577 Supplemented
Quality management system EU MDR
- Notified body
- Notified body 1639
- Issued
- 14 Apr 2025
- Expires
- 31 Mar 2028
- Reason
- Add device or group
Specification
- Model / Reference
- C30, C30A
- Primary DI / UDI-DI
- 06945429020328
- Basic UDI-DI
- 69454290PM001PA
- Direct Marketing DI
- 06945429020328
- EMDN Code
- Z1203020201 Multi–parameter patient bedside monitors
- Device Class
- Class IIb
- Market of Registration
- Ireland
Manufacturer details
- EUDAMED SRN
- CN-MF-000002236
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from Shenzhen Comen Medical Instruments Co., Ltd.
See all devices from Shenzhen Comen Medical Instruments Co., Ltd. →
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED da64424c-a626-4ff4-8f5e-204b82251b2d