Identity
- Trade Name
- MINDRAY FDA UDI
- Generic Name
- Electronic gravity infusion controller administration set FDA UDI
- Device Name
- Burettes Infusion Sets EUDAMED
- Model / Reference
- S-BS-002D EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972620118004 EUDAMEDFDA UDI
- Basic UDI-DI
- 697262011BQIV21DY EUDAMED
- 510(k) Number
- K210381 FDA UDI
- FDA Product Code
- FPA FDA UDI
- EMDN Code
- A03010103 INFUSION CONTROLLERS WITH FLOW REGULATOR EUDAMED
- GMDN Term
- Electronic gravity infusion controller administration set FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5440 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Burettes Infusion Sets by Bq Plus Medical Co., Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697262011BQIV21DY | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- BQ Plus Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000010259
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (2)
- EUDAMED d034f580-faed-433e-8df5-d70200518f98 61 fields · synced Jul 18, 2026
- FDA UDI a4bf6f5b-4b29-46f9-bf6c-1d382c749f45 33 fields · synced May 30, 2026