Infusion Pump
by Guangdong Biolight Meditech Co., Ltd United States EUDAMED
Ref BioFusion M500 ProModel BioFusion M500, BioFusion M500 Ex, BioFusion M500 Pro, Evadrop V10
EMDN Z12030301
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69325623300084V | Date10 Jul 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- BioFusion M500, BioFusion M500 Ex, BioFusion M500 Pro, Evadrop V10
- Primary DI / UDI-DI
- 06932562301841
- Basic UDI-DI
- 69325623300084V
- EMDN Code
- Z12030301 Infusion pumps
- Device Class
- Class IIb
- Market of Registration
- Germany
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 & 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 06932562301841|69325623300084V