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Infusion Sets with Light Resistant Function
EUDAMEDClass IIa (EU MDR)
Ref S-PL-005DRef BQ107Model Light Resistant lVAdministration SetRef ONF-BC1L1V4Ref BQ108Ref ONF-BC1L1V1Ref ONF-BC1L2U2Ref I-ISBRef ONF-BC1L2U1Ref BQIV25161Ref Fama-01Ref ONF-BC2L1V2Ref BQIV24319 Ref ONF-IVLPRef BQ109Ref Fama-02Ref ONF-BC2L1V1
Identity
- Device Name
- Infusion Sets with Light Resistant Function EUDAMED
- Model / Reference
- S-PL-005D EUDAMEDLight Resistant lVAdministration Set EUDAMEDBQ107 EUDAMEDONF-BC1L1V4 EUDAMEDBQ108 EUDAMEDONF-BC1L1V1 EUDAMEDONF-BC1L2U2 EUDAMEDI-ISB EUDAMEDONF-BC1L2U1 EUDAMEDBQIV25161 EUDAMEDFama-01 EUDAMEDONF-BC2L1V2 EUDAMEDBQIV24319 EUDAMEDONF-IVLP EUDAMEDBQ109 EUDAMEDFama-02 EUDAMEDONF-BC2L1V1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972620111296 EUDAMED08681529376627 EUDAMED06972620116796 EUDAMED08681529376634 EUDAMED06972620116802 EUDAMED06972620113672 EUDAMED06972620118981 EUDAMED06972620116697 EUDAMED06979864560125 EUDAMED16972620116007 EUDAMED06972620116765 EUDAMED06972620119261 EUDAMED06972620117663 EUDAMED08681529376641 EUDAMED16972620117110 EUDAMED06972620117649 EUDAMED
- Basic UDI-DI
- 697262011BQIV29EG EUDAMED697262011BQIV14E3 EUDAMED697262011BQIV15E5 EUDAMED
- Unit of Use DI
- 06972620112316 EUDAMED06972620112330 EUDAMED
- EMDN Code
- A03010103 INFUSION CONTROLLERS WITH FLOW REGULATOR EUDAMEDA03010101 INFUSION CONTROLLERS WITH OR W/O AIR INLET EUDAMEDA03010199 INFUSION CONTROLLERS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMED
- Market of Registration
- Italy EUDAMEDTürkiye EUDAMEDPoland EUDAMEDRomania 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 | 697262011BQIV29EG | 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 (16)
- EUDAMED bade3e38-6366-403c-99b1-049a8e36a26a 61 fields · synced Aug 2, 2026
- EUDAMED 8e1361b8-f090-4ef3-9de5-de1c57a641b5 61 fields · synced May 16, 2026
- EUDAMED 5145c3c9-f6b2-42ca-8173-a0472e7b7d9b 61 fields · synced May 16, 2026
- EUDAMED 5f6de403-d460-467e-b8f6-8bd52765026c 61 fields · synced May 17, 2026
- EUDAMED c62ab271-421a-4721-87b3-af5feaa137da 61 fields · synced May 17, 2026
- EUDAMED 2f16132e-b0a6-477a-b2f6-bef2e53eafa5 61 fields · synced May 17, 2026
- EUDAMED 98312f9c-0156-4716-9322-4bb040012c57 61 fields · synced May 17, 2026
- EUDAMED 40098a47-fd44-4a72-8992-0431a8001e82 61 fields · synced May 17, 2026
- EUDAMED 8c4eea6e-1384-494c-bbba-83bca8fbf1e7 61 fields · synced May 18, 2026
- EUDAMED 00d2cf65-6770-4ed9-88a3-b33a78fe7bc6 61 fields · synced May 18, 2026
- EUDAMED f0a75d28-f1e8-4694-9ff6-95dd35cd691a 61 fields · synced May 18, 2026
- EUDAMED f662894c-2463-4252-aea6-49de97a67679 61 fields · synced May 18, 2026
- EUDAMED dc55b906-25ba-4f4c-979b-ab59fb008e93 61 fields · synced May 18, 2026
- EUDAMED 2728fcf0-e854-4b22-bce6-b60057568191 61 fields · synced May 18, 2026
- EUDAMED f09e52ae-32a8-48ea-9046-11cd35e5ed90 61 fields · synced May 19, 2026
- EUDAMED e6ee219c-eb6d-4cfa-b7c8-be062ef6c49e 61 fields · synced May 19, 2026