Identity
- Trade Name
- MINDRAY FDA UDI
- Generic Name
- Intravenous administration tubing extension set FDA UDI
- Device Name
- Extension Sets EUDAMED
- Model / Reference
- S-ES-000 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972620114822 EUDAMEDFDA UDI
- Basic UDI-DI
- 697262011BQES5DK EUDAMED
- 510(k) Number
- K210381 FDA UDI
- FDA Product Code
- FPA FDA UDI
- EMDN Code
- A03020101 LOW PRESSURE EXTENSION LINES EUDAMED
- GMDN Term
- Intravenous administration tubing extension set FDA UDI
Classification
- Device Class
- Class I 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
Extension Sets by Bq Plus Medical Co., Ltd — Class I — 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 | 697262011BQES5DK | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 b45a8957-a059-4095-bd40-9832ac905e70 61 fields · synced Jun 18, 2026
- FDA UDI 199091b8-d9b9-4e71-8a4f-6993df80b822 33 fields · synced May 30, 2026