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Infusion Pump
EUDAMEDClass IIb (EU MDR)
Ref BioFusion S500 ProModel BioFusion S500
Identity
- Trade Name
- Infusion Pump EUDAMED
- Device Name
- Infusion Pump EUDAMED
- Model / Reference
- BioFusion S500 EUDAMEDBioFusion S500 Pro EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06932562301131 EUDAMED
- Basic UDI-DI
- 69325623300034K EUDAMED
- EMDN Code
- Z12030301 INFUSION PUMPS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Infusion Pump by Guangdong Biolight Meditech Co., Ltd — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69325623300034K | Class IIb | Active |
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Manufacturer
- Manufacturer
- Guangdong Biolight Meditech Co., Ltd
- EUDAMED SRN
- CN-MF-000006333
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 99c3daf6-031b-4654-afe4-661b63570cf4 61 fields · synced Jun 17, 2026