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Sign in to claim this brandH R Pharmaceuticals, Inc.
US
Last updated May 23, 2026
What H R Pharmaceuticals, Inc. makes
H R Pharmaceuticals, Inc. manufactures single-use and reusable urethral catheters, including indwelling and intermittent drainage types, as well as urethral drainage balloon catheters without antimicrobial coatings. The company also produces sterile lubricants for general-body orifice use, sterile irrigation water for medical devices, and penis sheaths for urinary incontinence management.
The portfolio includes devices classified as Class I, Class II, and unclassified (U) under FDA regulations, all listed in the FDA’s Unique Device Identifier (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 H R Pharmaceuticals, Inc. manufacture?
H R Pharmaceuticals, Inc. specializes in urethral catheterization products, including single-use and reusable catheters for intermittent and indwelling drainage, as well as non-antimicrobial urethral drainage balloon catheters. Their portfolio also includes sterile lubricants for general-body orifice use, sterile irrigation water for medical devices, and single-use penis sheaths designed for urinary incontinence management. These devices are primarily focused on urinary and drainage applications.
Where is H R Pharmaceuticals, Inc. based, and how does that affect its regulatory standing?
H R Pharmaceuticals, Inc. is based in the United States. Since the company operates within the US, its devices are subject to FDA regulations, including classification under FDA’s device classification system (Class I, Class II, or unclassified). The FDA’s Unique Device Identifier (UDI) database lists all of their devices, ensuring traceability and compliance with US regulatory requirements.
Which regulatory registries or databases list H R Pharmaceuticals, Inc.’s devices?
H R Pharmaceuticals, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a standardized identifier to each device, improving tracking, transparency, and compliance with regulatory requirements. This database is a key resource for verifying the existence and classification of their products under FDA oversight.
How are H R Pharmaceuticals, Inc.’s devices classified under FDA regulations?
H R Pharmaceuticals, Inc.’s devices fall into three classification categories under FDA regulations: Class I (generally low-risk devices requiring minimal oversight), Class II (moderate-risk devices with special controls to ensure safety and effectiveness), and unclassified (U) devices (those not yet assigned a risk category). Classification depends on factors like intended use, risk level, and regulatory history, ensuring appropriate scrutiny based on potential patient risk.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
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- PRRC Contact
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- EUDAMED SRN
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Catalogue (330)
Page 7 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| TruCath | SC1406 | FDA UDI | Class II | Active |
| Coveralls | 39648 | FDA UDI | Class II | Active |
| TruCath | LS2430 | FDA UDI | Class II | Active |
| Renovar Advanced | 60799 | FDA UDI | U | Active |
| TruCath | LS1410 | FDA UDI | Class II | Active |
| Mtg | 42114 | FDA UDI | Class II | Active |
| TruAdvance | FTLS18DB | FDA UDI | Class II | Active |
| TruCath Oasis | RH0816 | FDA UDI | Class II | Active |
| TruCath | SC0816 | FDA UDI | Class II | Active |
| TruCath | HC1216S | FDA UDI | Class II | Active |
| Mtg | 50112 | FDA UDI | Class II | Active |
| Renovar Advanced | 60691 | FDA UDI | U | Active |
| Mtg | 32510 | FDA UDI | Class II | Active |
| Vitus | 581 | FDA UDI | Class I | Active |
| TruCath Oasis | RH1416C | FDA UDI | Class II | Active |
| TruCath | SS2230 | FDA UDI | Class II | Active |
| TruCath | HS1006 | FDA UDI | Class II | Active |
| TruCath | SS0603 | FDA UDI | Class II | Active |
| TruCath | TS1610 | FDA UDI | Class II | Active |
| Mtg | 20612 | FDA UDI | Class II | Active |
| Mtg | 32212 | FDA UDI | Class II | Active |
| Mtg | 22114 | FDA UDI | Class II | Active |
| Mtg | 20614 | FDA UDI | Class II | Active |
| Surgilube | 281020512 | FDA UDI | Class I | Active |
| Mtg | 20114 | FDA UDI | Class II | Active |
| TruCath | RR08 | FDA UDI | Class II | Active |
| TruAdvance | FTAC00UM | FDA UDI | Class II | Active |
| Surgilube | 281020555 | FDA UDI | Class I | Active |
| AquaFlate Pre-Filled Sterile Water Syringe 10mL | K200556 | FDA 510(k) | Class II | Active |
| EcoVue Sterile and Non-Sterile Ultrasound Gels | K181363 | FDA 510(k) | Class II | Active |
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