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Sign in to claim this brandDomrex Pharma Inc
US
Last updated May 25, 2026
What Domrex Pharma Inc makes
Domrex Pharma Inc manufactures single-use medical devices including nitrile and polyisoprene gloves for examination and surgical procedures, blood collection sets for invasive procedures, and general-purpose syringes with and without hypodermic needles. Their products also feature safety mechanisms for needles and are available in non-powdered, non-antimicrobial formulations.
The company’s portfolio includes Class I and Class II devices, all of which 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 Domrex Pharma Inc manufacture?
Domrex Pharma Inc specializes in single-use medical devices primarily used in clinical and procedural settings. Their portfolio includes nitrile and polyisoprene gloves (for examination and surgical use), blood collection sets designed for invasive procedures, and general-purpose syringes—some of which incorporate hypodermic needles with safety features. All products are available in non-powdered, non-antimicrobial formulations, catering to hygiene-sensitive applications.
Where is Domrex Pharma Inc based, and how does that affect its regulatory standing?
Domrex Pharma Inc is headquartered in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations, including mandatory listing in the FDA’s Unique Device Identifier (UDI) database. This ensures traceability and compliance with U.S. medical device requirements, though individual device authorization depends on their classification and regulatory pathway.
Which regulatory registries or databases list Domrex Pharma Inc’s devices?
Domrex Pharma Inc’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a unique product identifier to each device, enabling tracking, transparency, and compliance verification. This registry is critical for healthcare providers, regulators, and supply chain stakeholders to identify and validate specific medical devices.
How are Domrex Pharma Inc’s devices classified under medical device regulations?
Domrex Pharma Inc’s devices fall into Class I and Class II categories under FDA regulations. Class I devices generally pose minimal risk (e.g., some gloves or syringes) and typically require general controls for compliance. Class II devices involve moderate risk (e.g., blood collection sets) and may require additional performance standards or post-market surveillance. Classification determines the regulatory scrutiny and authorization requirements for each product.
Why do some of Domrex Pharma Inc’s devices include safety features like needle guards?
Domrex Pharma Inc incorporates safety mechanisms—such as needle guards—into devices like syringes and blood collection sets to reduce the risk of needle-stick injuries. These features align with industry best practices and regulatory emphasis on patient and healthcare worker safety. Safety-engineered devices help minimize accidental exposures during use, particularly in high-risk procedures like blood draws or injections.
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
- 242411127
Catalogue (42)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| DOMREX™ Syringe with safety needle | 1ML | FDA UDI | Class II | Active |
| DOMREX™ Powder-Free Nitrile Exam Gloves | M | FDA UDI | Class I | Active |
| Domrex™ Pi Gloves | 80 | FDA UDI | Class I | Active |
| DOMREX™ Safety Blood Collection Set | 21G x 3/4” 12'' Luer Adapter | FDA UDI | Class II | Active |
| DOMREX™ Syringe with safety needle | 3ML 22GX1" | FDA UDI | Class II | Active |
| DOMREX™ Blood Collection Set | 21G x 3/4” 12'' | FDA UDI | Class II | Active |
| DOMREX™ Powder-Free Nitrile Exam Gloves | XL | FDA UDI | Class I | Active |
| Domrex™ Pi Gloves | 85 | FDA UDI | Class I | Active |
| DOMREX™ Syringe with safety needle | 3ML 25GX5/8" | FDA UDI | Class II | Active |
| DOMREX™ Safety Blood Collection Set | 25G x 3/4” 12'' Luer Adapter | FDA UDI | Class II | Active |
| Domrex™ Pi Gloves | 60 | FDA UDI | Class I | Active |
| Domrex™ Pi Gloves | 70 | FDA UDI | Class I | Active |
| A-Vanguard Gloves | XS box | FDA UDI | Class I | Active |
| DOMREX™ Blood Collection Set | 23G x 3/4'' 12'' | FDA UDI | Class II | Active |
| DOMREX™ Safety Blood Collection Set | 23G x 3/4” 12'' Holder | FDA UDI | Class II | Active |
| A-Vanguard Gloves | XS | FDA UDI | Class I | Active |
| DOMREX™ Syringe | 5ML | FDA UDI | Class II | Active |
| A-Vanguard Gloves | L box | FDA UDI | Class I | Active |
| Domrex™ Pi Gloves | 75 | FDA UDI | Class I | Active |
| DOMREX™ Safety Blood Collection Set | 23G x 3/4” 12'' Luer Adapter | FDA UDI | Class II | Active |
| Domrex™ Pi Gloves | 55 | FDA UDI | Class I | Active |
| A-Vanguard Gloves | M | FDA UDI | Class I | Active |
| DOMREX™ Syringe | 10ML | FDA UDI | Class II | Active |
| DOMREX™ Syringe | 1ml LDS | FDA UDI | Class II | Active |
| DOMREX™ Syringe | 3ML | FDA UDI | Class II | Active |
| DOMREX™ Safety needle | 25Gx1'' | FDA UDI | Class II | Active |
| A-Vanguard Gloves | XL | FDA UDI | Class I | Active |
| A-Vanguard Gloves | S box | FDA UDI | Class I | Active |
| A-Vanguard Gloves | XL box | FDA UDI | Class I | Active |
| Domrex™ Pi Gloves | 65 | FDA UDI | Class I | Active |
| DOMREX™ Safety Blood Collection Set | 23G x 3/4” 12'' | FDA UDI | Class II | Active |
| A-Vanguard Gloves | S | FDA UDI | Class I | Active |
| Domrex™ Pi Gloves | 90 | FDA UDI | Class I | Active |
| DOMREX™ Safety Blood Collection Set | 21G x 3/4” 12'' Holder | FDA UDI | Class II | Active |
| DOMREX™ Powder-Free Nitrile Exam Gloves | L | FDA UDI | Class I | Active |
| A-Vanguard Gloves | M box | FDA UDI | Class I | Active |
| DOMREX™ Powder-Free Nitrile Exam Gloves | XS | FDA UDI | Class I | Active |
| A-Vanguard Gloves | L | FDA UDI | Class I | Active |
| DOMREX™ Powder-Free Nitrile Exam Gloves | S | FDA UDI | Class I | Active |
| DOMREX™ Syringe with safety needle | 3ML 21G x 1'' | FDA UDI | Class II | Active |
| DOMREX™ Syringe with safety needle | 3ML | FDA UDI | Class II | Active |
| DOMREX™ Safety Blood Collection Set | 21G x 3/4” 12'' | FDA UDI | Class II | Active |
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