Is this your brand? Sign in to claim ownership.
Sign in to claim this brandWhat BQ PLUS MEDICAL CO., LTD. makes
BQ Plus Medical Co., Ltd. manufactures intravenous administration products, including tubing extension sets, basic noninvasive intravenous sets, and electronic gravity infusion controllers. Their portfolio also covers Luer/Luer connectors and blood transfusion sets designed for single-use. These devices are used in fluid administration and transfusion procedures.
The company’s products are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does BQ Plus Medical Co., Ltd. primarily manufacture?
BQ Plus Medical Co., Ltd. specializes in intravenous administration devices. Their portfolio includes tubing extension sets, basic noninvasive intravenous administration sets, electronic gravity infusion controllers, Luer/Luer linear connectors, and blood transfusion sets—all designed for single-use. These products support fluid administration and transfusion procedures in clinical settings.
Where is BQ Plus Medical Co., Ltd. based, and how does that affect its regulatory landscape?
The company is based in the United States, which means its devices are subject to FDA regulations. Since they fall under Class II classification, they require premarket notification (510(k)) clearance before commercial distribution, though the company’s specific devices are listed in the FDA’s UDI database for traceability and compliance tracking.
Which regulatory registries or databases list BQ Plus Medical Co., Ltd.’s devices?
BQ Plus Medical Co., Ltd.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry ensures transparency in device identification, tracking, and compliance with U.S. regulatory requirements, particularly for Class II products like theirs.
How are BQ Plus Medical Co., Ltd.’s devices classified under FDA regulations, and why does this matter?
The company’s devices are classified as Class II under FDA regulations. This classification indicates a moderate level of risk and requires compliance with special controls, such as premarket notification (510(k)) submissions, to ensure safety and effectiveness before they can be marketed in the U.S. Class II status also means these devices undergo additional scrutiny compared to Class I items.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 544463583
Catalogue (107)
Page 2 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Bq+ | BW/IVF-3041230 | FDA UDI | Class II | Active |
| Nfuze | BNS103 | FDA UDI | Class II | Unknown |
| Nfuze | PNS003 | FDA UDI | Class II | Unknown |
| Nfuze | PCS303 | FDA UDI | Class II | Unknown |
| Imed | IM41000 | FDA UDI | Class II | Active |
| Imed | IM42073 | FDA UDI | Class II | Active |
| Nfuze | PVS203 | FDA UDI | Class II | Active |
| Mindray | S-IS-002D | FDA UDI | Class II | Active |
| Imed | IM42075 | FDA UDI | Class II | Active |
| Mindray | S-PS-002D | FDA UDI | Class II | Active |
| Nfuze | PNS003 | FDA UDI | Class II | Unknown |
| Bq+ | BW/IVF-3041230 | FDA UDI | Class II | Active |
| Bq+ | BW/IV-3041185 | FDA UDI | Class II | Active |
| Mindray | S-PS-102D | FDA UDI | Class II | Active |
| Mindray | S-PS-003D | FDA UDI | Class II | Active |
| Nfuze | EJN002 | FDA UDI | Class II | Active |
| Imed | IM42076 | FDA UDI | Class II | Active |
| Imed | IM41018 | FDA UDI | Class II | Active |
| Imed | IM41018 | FDA UDI | Class II | Active |
| Imed | IM42073 | FDA UDI | Class II | Active |
| Nfuze | MLN002 | FDA UDI | Class II | Active |
| Nfuze | MKN000 | FDA UDI | Class II | Active |
| Nfuze | MJN002 | FDA UDI | Class II | Active |
| Nfuze | MKN000 | FDA UDI | Class II | Active |
| Right Way Medical | RWM-IFRF01 | FDA UDI | Class II | Active |
| Imed | IM42071 | FDA UDI | Class II | Active |
| Nfuze | PRS401 | FDA UDI | Class II | Unknown |
| Imed | IM41002 | FDA UDI | Class II | Active |
| Nfuze | BNS103 | FDA UDI | Class II | Unknown |
| Merit | EX004B | FDA UDI | Class II | Active |
| Imed | IM42072 | FDA UDI | Class II | Active |
| Nfuze | CSN002 | FDA UDI | Class II | Active |
| Nfuze | MSN002 | FDA UDI | Class II | Active |
| Imed | IM41000 | FDA UDI | Class II | Active |
| Imed | IM41001 | FDA UDI | Class II | Active |
| Nfuze | ELN002 | FDA UDI | Class II | Active |
| Nfuze | PFS103 | FDA UDI | Class II | Active |
| Nfuze | MSN002 | FDA UDI | Class II | Active |
| Nfuze | HNS003 | FDA UDI | Class II | Unknown |
| Imed | IM42074 | FDA UDI | Class II | Active |
| Imed | IM42076 | FDA UDI | Class II | Active |
| Mindray | S-LS-002D | FDA UDI | Class II | Active |
| Nfuze | SS300 | FDA UDI | Class II | Active |
| Mindray | S-TS-000D | FDA UDI | Class II | Active |
| Nfuze | CSN002 | FDA UDI | Class II | Active |
| Nfuze | MSN002 | FDA UDI | Class II | Active |
| Nfuze | PVS203 | FDA UDI | Class II | Unknown |
| Nfuze | BCS203 | FDA UDI | Class II | Unknown |
| Nfuze | MLN002 | FDA UDI | Class II | Active |
| Imed | IM42075 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.