Syringe Pump
by Guangdong Biolight Meditech Co., Ltd 13 variants
Ref BioFusion S300 ProModel BioFusion S300, BioFusion S300 Neo, BioFusion S300 Ex, BioFusion S300 Pro, BioFusion P300, BioFusion P300 Neo, BioFusion P300 Ex, BioFusion P300 Pro, CODAN 806 S
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 | Number69325623300044M 06932562301179 | Date25 Jun 2025 | 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- Withdrawn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
- Model / Reference
- BioFusion S300, BioFusion S300 Neo, BioFusion S300 Ex, BioFusion S300 Pro, BioFusion P300, BioFusion P300 Neo, BioFusion P300 Ex, BioFusion P300 Pro, CODAN 806 S
- Primary DI / UDI-DI
- 06932562301179
- Basic UDI-DI
- 69325623300044M
- EMDN Code
- Z12030302 Syringe pumps
- Device Class
- Class IIb
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- CN-MF-000006333
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Guangdong Biolight Meditech Co., Ltd
Properties
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