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Sign in to claim this brandPendracare International, B.V.
US
Last updated May 27, 2026
What Pendracare International, B.V. makes
Pendracare International manufactures single-use vascular guide-catheters and urodynamic catheters, designed for procedural and diagnostic applications in vascular and urological settings.
The company’s products are classified as Class II devices and are listed in the FDA’s Unique Device Identifier (UDI) database, adhering to U.S. regulatory requirements.
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 Pendracare International, B.V. manufacture?
Pendracare International, B.V. specializes in single-use medical devices, specifically vascular guide-catheters and urodynamic catheters. These devices are designed for use in vascular and urological procedures, including both diagnostic and interventional applications. The company’s focus on single-use products ensures compliance with procedural hygiene standards.
Where is Pendracare International, B.V. based, and does this affect its regulatory compliance?
Pendracare International, B.V. is based in the United States, which means its devices must comply with U.S. regulatory requirements. The company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, demonstrating adherence to U.S. regulatory standards for medical devices. This listing helps ensure traceability and transparency in the supply chain.
Which regulatory registries or databases list Pendracare International’s devices?
Pendracare International’s devices are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system is a global standard for identifying medical devices, ensuring accurate tracking and regulatory compliance. Listing in this database is particularly relevant for Class II devices, which require additional scrutiny due to their moderate risk.
How are Pendracare International’s devices classified under U.S. regulations?
Pendracare International’s devices are classified as Class II under U.S. regulations. This classification is based on their intended use and associated risks—vascular guide-catheters and urodynamic catheters fall into this category because they pose moderate risks and require special controls to ensure safety and effectiveness. Class II devices undergo additional review processes to validate their performance and compliance.
Why does it matter that Pendracare International’s devices are listed in the FDA’s UDI database?
Listing in the FDA’s UDI database is critical because it provides a standardized way to identify and track medical devices throughout their lifecycle, from manufacturing to patient use. This system enhances transparency, reduces medical errors, and supports regulatory oversight. For Class II devices like those made by Pendracare International, the UDI ensures that healthcare providers and regulators can quickly access accurate information about the device’s specifications, compliance status, and potential recalls.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- xx.xx
- —
- —
- [email protected]
- Phone
- 888-272-1001
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 413008652
Catalogue (539)
Page 4 of 11| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Convey | 7F Convey FCL3 SH | FDA UDI | Class II | Active |
| Convey | 7F Convey IM | FDA UDI | Class II | Active |
| Convey | 7F Convey FR6 | FDA UDI | Class II | Active |
| Convey | 6FConvey AL.75 SH | FDA UDI | Class II | Active |
| Convey | 8F Convey CLS4 | FDA UDI | Class II | Active |
| Convey | 8F Convey CLS3.5 | FDA UDI | Class II | Active |
| Convey | 8F Convey LeftBU5 | FDA UDI | Class II | Active |
| Convey | 6FConvey AL1 | FDA UDI | Class II | Active |
| Convey | 6FConvey LeftBU5 SH | FDA UDI | Class II | Active |
| Convey | 6F Convey RCB SH | FDA UDI | Class II | Active |
| Convey | 6FConvey JR3 | FDA UDI | Class II | Active |
| Convey | 6FConvey HS | FDA UDI | Class II | Active |
| Convey | 6FConvey FR4 | FDA UDI | Class II | Active |
| Convey | 6FConvey FL4 | FDA UDI | Class II | Active |
| Convey | 6FConvey JR4 | FDA UDI | Class II | Active |
| Convey | 7F Convey AR1 | FDA UDI | Class II | Active |
| Convey | 6FConvey JL6 | FDA UDI | Class II | Active |
| Convey | 6FConvey RBL4 SH | FDA UDI | Class II | Active |
| Convey | 6FConvey AL1 SH | FDA UDI | Class II | Active |
| Convey | 6FConvey CLS3.5 SH | FDA UDI | Class II | Active |
| Convey | 6FConvey RADIAL SH | FDA UDI | Class II | Active |
| Convey | 8F Convey ART3 SH | FDA UDI | Class II | Active |
| Convey | 7F Convey JL6 SH | FDA UDI | Class II | Active |
| Convey | 6FConvey FR6 | FDA UDI | Class II | Active |
| Convey | 7F Convey RBL3.5 SH | FDA UDI | Class II | Active |
| Convey | 8F Convey LeftBU3.5 SH | FDA UDI | Class II | Active |
| Convey | 6FConvey TIG3.5 | FDA UDI | Class II | Active |
| Convey | 8F Convey AL1 SH | FDA UDI | Class II | Active |
| Convey | 8F Convey FR5 | FDA UDI | Class II | Active |
| Convey | 6FConvey JR4 SH | FDA UDI | Class II | Active |
| Convey | 6FConvey FR3 SH | FDA UDI | Class II | Active |
| Convey | 6FConvey LeftBU3.75 SH | FDA UDI | Class II | Active |
| Convey | 8F Convey AL1.5 | FDA UDI | Class II | Active |
| Convey | 5FConvey RCB | FDA UDI | Class II | Active |
| Convey | 7F Convey LeftBU4 | FDA UDI | Class II | Active |
| Convey | 7F Convey AR2 SH | FDA UDI | Class II | Active |
| Convey | 8F Convey FCL3.5 | FDA UDI | Class II | Active |
| Convey | 6FConvey TIG3 | FDA UDI | Class II | Active |
| Convey | 5FConvey FL4.5 | FDA UDI | Class II | Active |
| Convey | 7F Convey JR4 SH | FDA UDI | Class II | Active |
| e∙Sense | Abdominal Catheter | FDA UDI | Class II | Active |
| Convey | 7F Convey JR6 | FDA UDI | Class II | Active |
| Convey | 6FConvey FCL3 SH | FDA UDI | Class II | Active |
| Convey | 7F Convey CLS4.5 SH | FDA UDI | Class II | Active |
| Convey | 7F Convey CLS4 | FDA UDI | Class II | Active |
| Convey | 7F Convey AL1 | FDA UDI | Class II | Active |
| e∙Sense | Bladder Single Sensor Catheter; Coudé tip shape | FDA UDI | Class II | Active |
| Convey | 6FConvey KIMNY SH | FDA UDI | Class II | Active |
| Convey | 8F Convey AL.75 SH | FDA UDI | Class II | Active |
| Convey | 6FConvey FCL5 | FDA UDI | Class II | Active |
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