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Infusion Sets with Light Resistant Function
EUDAMEDClass IIa (EU MDR)
Ref ONF-BC1L2U4
Identity
- Device Name
- Infusion Sets with Light Resistant Function EUDAMED
- Model / Reference
- ONF-BC1L2U4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972620113818 EUDAMED
- Basic UDI-DI
- 697262011BQIV15E5 EUDAMED
- EMDN Code
- A03010103 INFUSION CONTROLLERS WITH FLOW REGULATOR 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 ec7b7e22-ae19-463d-ba53-1a64e348d5c7 61 fields · synced Jun 18, 2026