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Infusion Sets with Light Resistant Function
EUDAMEDClass IIa (EU MDR)
Ref ONF-IVLPF
Identity
- Device Name
- Infusion Sets with Light Resistant Function EUDAMED
- Model / Reference
- ONF-IVLPF EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972620117762 EUDAMED
- Basic UDI-DI
- 697262011BQIV15E5 EUDAMED
- EMDN Code
- A03010102 INFUSION CONTROLLERS WITH FILTER (ALSO TRANSFUSION CONTROLLERS) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye 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 with Light Resistant Function 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 | 697262011BQIV15E5 | 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 (1)
- EUDAMED 6bf6b933-98b1-4b54-908d-2a4dd6f2d0b5 61 fields · synced Jun 19, 2026