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US
Last updated May 23, 2026
What HEPRO.US INC. makes
The company manufactures single-use medical barriers and injection devices, including nitrile and latex gloves for examination and surgical procedures, as well as non-powdered, non-antimicrobial variants. It also produces general-purpose and insulin syringes with attached needles, hypodermic needles, surgical gowns, and examination/surgical garment kits. Additional offerings include Mayo stand covers and tuberculin syringes, all designed for healthcare settings.
These products are regulated under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States, adhering to applicable U.S. medical device regulations.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What medical devices does HEPRO.US INC. manufacture?
HEPRO.US INC. produces single-use medical barriers and injection devices, including nitrile and latex gloves for examination and surgical procedures, non-powdered, non-antimicrobial variants, general-purpose and insulin syringes with attached needles, hypodermic needles, surgical gowns, examination/surgical garment kits, Mayo stand covers, and tuberculin syringes.
Where is HEPRO.US INC. based?
HEPRO.US INC. operates from the United States, adhering to applicable U.S. medical device regulations for all its manufactured products.
Which regulatory registries list HEPRO.US INC.'s devices?
HEPRO.US INC.'s devices are listed in the FDA's Unique Device Identifier (UDI) database, which tracks medical devices sold in the United States.
How are HEPRO.US INC.'s medical devices classified?
HEPRO.US INC.'s devices are regulated under FDA's Class I and Class II categories, with Class I being lower risk and Class II requiring more regulatory controls than Class I devices.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 080061451
Catalogue (105)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| HEPRO.US Syringe with needle 1ml/cc 28G x1/2" | BX - 1ml/cc 28G x1/2" | FDA UDI | Class II | Active |
| HEPRO.US Welcome Pack - Case | CT - Welcome Pack | FDA UDI | Class II | Active |
| HEPRO.US- Exam Class Latex Gloves Size X-Large - Case | CT - Latex Exam XL | FDA UDI | Class I | Active |
| HEPRO.US - Syringe with needle 3ml/cc 22G x 3/4" - 12 Boxes per 1 Case | CT- 3 ml/cc 22G x 3/4" | FDA UDI | Class II | Active |
| HEPRO.US Lab Suit 1 Pouch | Single Pouch Lab Suit | FDA UDI | Class I | Active |
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