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Syringe Pump
EUDAMEDClass IIb (EU MDR)
Ref BioFusion P300 NeoModel BioFusion S300Ref BioFusion P300Ref CODAN 806 SRef BioFusion S300 ExRef BioFusion S300 Pro
Identity
- Trade Name
- Syringe Pump EUDAMED
- Device Name
- Syringe Pump EUDAMED
- Model / Reference
- BioFusion S300 EUDAMEDBioFusion P300 Neo EUDAMEDBioFusion P300 EUDAMEDCODAN 806 S EUDAMEDBioFusion S300 Ex EUDAMEDBioFusion S300 Pro EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06932562301742 EUDAMED06932562301728 EUDAMED06932562301940 EUDAMED06932562301162 EUDAMED06932562301179 EUDAMED
- Basic UDI-DI
- 69325623300044M EUDAMED
- EMDN Code
- Z12030302 SYRINGE PUMPS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland EUDAMEDGermany 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
Syringe 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 | 69325623300044M | 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 (5)
- EUDAMED b82318aa-9f78-4625-a80c-77dcbb35a323 61 fields · synced Jul 26, 2026
- EUDAMED 519c9b2c-247f-4328-b63f-782661d8b479 61 fields · synced May 17, 2026
- EUDAMED fbc00a4e-a904-49be-9fe5-49e5d2332d37 61 fields · synced May 18, 2026
- EUDAMED 1a2ef107-dda8-4210-ab97-c18df313e09b 61 fields · synced May 19, 2026
- EUDAMED 9b8fb1da-0178-4d23-a5e8-c8e01ede5c30 61 fields · synced May 19, 2026