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Infusion Sets Used with Pressure Infusion Equipment
EUDAMEDClass IIa (EU MDR)
Ref S-PS-201DRef BQIV24320Ref BQIV24317Ref S-PS-004D
Identity
- Device Name
- Infusion Sets Used with Pressure Infusion Equipment EUDAMED
- Model / Reference
- S-PS-201D EUDAMEDBQIV24320 EUDAMEDBQIV24317 EUDAMEDS-PS-004D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972620111494 EUDAMED06972620119308 EUDAMED06972620119605 EUDAMED06972620111319 EUDAMED
- Basic UDI-DI
- 697262011BQIV22E2 EUDAMED697262011BQIV8EN EUDAMED
- EMDN Code
- A03010103 INFUSION CONTROLLERS WITH FLOW REGULATOR EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMEDPoland EUDAMED
Clinical & Handling
Sterile
Yes
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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Infusion Sets Used with Pressure Infusion Equipment by Bq Plus Medical Co., Ltd — Class IIa — 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 | 697262011BQIV22E2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- BQ Plus Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000010259
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (4)
- EUDAMED 179dcaa5-ac9a-41a9-b235-6e12e1ccc911 61 fields · synced Jul 29, 2026
- EUDAMED 70f92420-2e72-4980-851d-1e3fdf3ba14f 61 fields · synced May 16, 2026
- EUDAMED eee44160-5d77-4af0-aeef-2296ed45c4d3 61 fields · synced May 18, 2026
- EUDAMED f3a4bfe5-950a-42b7-98c3-ba293dd21d26 61 fields · synced May 19, 2026