Syringe Pump

by Guangdong Biolight Meditech Co., Ltd United States EUDAMED

Ref BioFusion S300 ExModel BioFusion S300

EMDN Z12030302

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number69325623300044M Basic UDI-DI	Date25 Jun 2025Registered	StatusActive

Coverage

1 jurisdiction

Active
Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference: BioFusion S300, BioFusion S300 Ex

Primary DI / UDI-DI: 06932562301162
Basic UDI-DI: 69325623300044M
EMDN Code: Z12030302 Syringe pumps

Device Class: Class IIb
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

ECG cable

Class I
NIBP hose

Class I
C.O. Extension cable

Class I
Infusion Pump

Class IIb
IBP Extension cable

Class I
NIBP cuff

Class I

See all devices from Guangdong Biolight Meditech Co., Ltd →

Properties & raw data

Show properties, registry sources and raw records

Administering Medicine
Measuring Function

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 1a2ef107-dda8-4210-ab97-c18df313e09b 61 fields · synced 22 Oct 2026