Ventilator
by Shenzhen Comen Medical Instruments Co., LTD. China EUDAMED
Ref V5BModel V2
EMDN Z1203010504
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberFI23/1008002 | Date17 Jun 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- FI23/1008002 Supplemented
Quality management system EU MDR
- Notified body
- SGS FIMKO OY 0598
- Issued
- 17 Jun 2026
- Expires
- 5 Sep 2028
- Reason
- Add device or group
Specification
- Model / Reference
- V2, V5B
- Primary DI / UDI-DI
- 06945429024890
- Basic UDI-DI
- 69454290GV004NC
- Direct Marketing DI
- 06945429024890
- EMDN Code
- Z1203010504 Adult and paediatric/neonatal pulmonary ventilators
- 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 (11)
- 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
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED d8e847c9-7719-497c-b31a-533531ad51f4