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Sign in to claim this brandBELLUSCURA PLC
US
Last updated May 27, 2026
What BELLUSCURA PLC makes
BellusCura PLC manufactures mobile and portable oxygen concentrators, including the X-PLO2R series, designed for on-the-go oxygen therapy. The company also produces single-use laparoscopic access cannulas, such as the Passport SmartTip Trocar and DISCOV-R, used in minimally invasive surgical procedures.
All devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identification (UDI) database. The company operates from 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 BellusCura PLC manufacture?
BellusCura PLC specializes in two primary categories of medical devices: mobile/portable oxygen concentrators, such as the X-PLO2R series, which are designed for patients requiring oxygen therapy while on the move. Additionally, the company produces single-use laparoscopic access cannulas, including the Passport SmartTip Trocar and DISCOV-R, which are used in minimally invasive surgical procedures to provide controlled access to the abdominal cavity.
Where is BellusCura PLC based?
BellusCura PLC is headquartered in the United States. The company’s location is relevant for regulatory oversight, as its devices are subject to FDA regulations and compliance requirements applicable in the US.
Which regulatory registries list BellusCura PLC’s devices?
BellusCura PLC’s devices are listed in the FDA’s Unique Device Identification (UDI) database. This registry ensures traceability and transparency in the medical device supply chain, allowing healthcare providers and regulators to verify device details, such as manufacturer information and classification.
How are BellusCura PLC’s devices classified under FDA regulations?
All of BellusCura PLC’s devices fall under Class II classification according to FDA regulations. This classification typically applies to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- belluscura.com
- —
- —
- [email protected]
- Phone
- (877)-469-7567
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 221297691
Catalogue (29)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| X-Plo2r | 50051-US-002-RE | FDA UDI | Class II | Active |
| X-Plo2r | 50188 | FDA UDI | Class II | Active |
| Discov-R | 70051 | FDA UDI | Class II | Active |
| Discov-R | 72291 | FDA UDI | Class II | Active |
| Passport SmartTip Trocar | 8.5mmx100mm | FDA UDI | Class II | Active |
| X-Plo2r | 50073 | FDA UDI | Class II | Active |
| Discov-R | 72191 | FDA UDI | Class II | Active |
| X-Plo2r | 50051-US-001 | FDA UDI | Class II | Active |
| X-Plo2r | 50051-HK-001 | FDA UDI | Class II | Active |
| X-Plo2r | 52051-US-002 | FDA UDI | Class II | Unknown |
| X-Plo2r | 52291 | FDA UDI | Class II | Active |
| Discov-R | 70051-US-005 | FDA UDI | Class II | Active |
| X-Plo2r | 50051-1 | FDA UDI | Class II | Active |
| X-Plo2r | 50073 | FDA UDI | Class II | Active |
| X-Plo2r | 50351 | FDA UDI | Class II | Active |
| X-Plo2r | 50051-US-002 | FDA UDI | Class II | Active |
| Discov-R | 70051-US-001 | FDA UDI | Class II | Active |
| Discov-R | 70188 | FDA UDI | Class II | Active |
| Discov-R | 70351 | FDA UDI | Class II | Unknown |
| X-Plo2r | 50051-US-003 | FDA UDI | Class II | Active |
| X-Plo2r | 50084 | FDA UDI | Class II | Active |
| X-Plo2r | 52191 | FDA UDI | Class II | Active |
| Discov-R | 70051-US-004 | FDA UDI | Class II | Active |
| X-Plo2r | 50051-1-RE | FDA UDI | Class II | Active |
| Discov-R | 70073 | FDA UDI | Class II | Unknown |
| X-Plo2r | 52051-US-001 | FDA UDI | Class II | Active |
| X-Plo2r | 50051-US-001-RE | FDA UDI | Class II | Active |
| Discov-R | 72391 | FDA UDI | Class II | Unknown |
| Discov-R | 70051-US-002 | FDA UDI | Class II | Active |
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