Identity
- Trade Name
- MINDRAY FDA UDI
- Generic Name
- Blood transfusion set, non-exchange FDA UDI
- Device Name
- Transfusion Sets EUDAMED
- Model / Reference
- S-TS-000D EUDAMEDFDA UDIS-TS-001D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972620113009 EUDAMEDFDA UDI06972620111357 EUDAMED
- Basic UDI-DI
- 697262011BQBS3CY EUDAMED697262011BQBS4D2 EUDAMED
- 510(k) Number
- K210381 FDA UDI
- FDA Product Code
- FPA FDA UDI
- EMDN Code
- A03010103 INFUSION CONTROLLERS WITH FLOW REGULATOR EUDAMED
- GMDN Term
- Blood transfusion set, non-exchange 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
Transfusion 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 | 697262011BQBS3CY | 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 (3)
- EUDAMED 2f6905bb-8c4a-414d-9f94-049e6a21d9f0 61 fields · synced Jul 17, 2026
- EUDAMED cb15b34b-2540-41d6-841f-4e78b3143373 61 fields · synced May 18, 2026
- FDA UDI f3df9e14-15d5-442e-9174-395b4c69772e 33 fields · synced May 30, 2026