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Sign in to claim this brandMHC Medical Products
US
Last updated September 17, 2026
What MHC Medical Products makes
MHC Medical Products manufactures single-use insulin syringes and needles, including basic and safety variants, as well as general-purpose syringes. Their portfolio also includes manual blood lancing devices for point-of-care use and home-use blood glucose and blood pressure monitoring systems, some of which incorporate IVD glucose monitoring components.
The company’s devices are classified under FDA regulations as Class I and Class II, with submissions recorded in the FDA’s 510(k) and UDI databases. Products are listed under U.S. regulatory frameworks, and the manufacturer 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 MHC Medical Products manufacture?
MHC Medical Products specializes in single-use medical devices primarily for diabetes management and point-of-care testing. Their portfolio includes insulin syringes and needles (both basic and safety variants), general-purpose syringes, manual blood lancing devices, and home-use blood glucose/blood pressure monitoring systems. Some of their monitoring systems also incorporate in-vitro diagnostic (IVD) components for glucose testing, catering to both self-monitoring and clinical settings.
Where is MHC Medical Products based, and how does that affect its regulatory standing?
MHC Medical Products is based in the United States, which means its devices are subject to U.S. regulatory frameworks like those administered by the FDA. Since the company operates domestically, its products are listed under U.S. regulatory databases such as the FDA’s 510(k) premarket notifications and UDI (Unique Device Identification) system. This ensures compliance with U.S. requirements for device classification, labeling, and post-market surveillance.
Which regulatory registries or databases list MHC Medical Products’ devices?
MHC Medical Products’ devices are recorded in the FDA’s official registries, specifically the 510(k) database for premarket submissions and the UDI (Unique Device Identification) system. These databases track device classifications, submissions, and compliance data, ensuring transparency for healthcare providers and regulators. The inclusion in these systems reflects the company’s adherence to U.S. medical device regulations.
How are MHC Medical Products’ devices classified under FDA regulations?
MHC Medical Products’ devices fall under two FDA classification tiers: Class I and Class II. Class I devices generally pose the lowest risk and may require general controls, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and regulatory history, as outlined in the FDA’s medical device regulations.
What distinguishes MHC Medical Products’ insulin syringes and needles from other similar products?
MHC Medical Products offers a range of insulin syringes and needles designed for precision and user convenience, including basic and safety variants. Their safety needles, for example, are engineered to reduce the risk of needle-stick injuries, a common concern in diabetes management. Additionally, their single-use syringes and needles are optimized for hygiene and accuracy in insulin delivery, aligning with FDA standards for Class I and Class II devices in this category.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 8695 Seward Road, Fairfield, OH, 45011
- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
- —
- FDA FEI Number
- 3005798905
- DUNS Number
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Catalogue (252)
Page 4 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| EasyTouch | 802001 | FDA UDI | Class II | Active |
| EasyTouch | 842511 | FDA UDI | Class II | Active |
| EasyTouch | 822237 | FDA UDI | Class II | Active |
| EasyTouch | 830565 | FDA UDI | Class II | Active |
| EasyTouch | 821807 | FDA UDI | Class II | Active |
| EasyTouch | 832551 | FDA UDI | Class II | Active |
| EasyTouch | 822331 | FDA UDI | Class II | Active |
| EasyTouch | 802401 | FDA UDI | Class II | Active |
| EasyTouch | 822057 | FDA UDI | Class II | Active |
| EasyTouch | 811907 | FDA UDI | Class II | Active |
| EasyTouch | 822157 | FDA UDI | Class II | Active |
| EasyTouch | 811801 | FDA UDI | Class II | Active |
| EasyTouch | 822101 | FDA UDI | Class II | Active |
| EasyTouch | 831030 | FDA UDI | Class II | Active |
| EasyTouch | 828155 | FDA UDI | Class II | Active |
| EasyTouch | 862955 | FDA UDI | Class II | Active |
| EasyTouch | 802010 | FDA UDI | Class II | Active |
| EasyTouch | 832531 | FDA UDI | Class II | Active |
| EasyTouch | 821316 | FDA UDI | Class II | Active |
| EasyTouch | 821837 | FDA UDI | Class II | Active |
| EasyTouch | 832257 | FDA UDI | Class II | Active |
| EasyTouch | 801807 | FDA UDI | Class II | Active |
| EasyTouch | 862915 | FDA UDI | Class II | Active |
| EasyTouch | 832107 | FDA UDI | Class II | Active |
| EasyTouch | 812207 | FDA UDI | Class II | Active |
| EasyTouch | 842538 | FDA UDI | Class II | Active |
| EasyTouch | 872531 | FDA UDI | Class II | Active |
| EasyTouch | 837215 | FDA UDI | Class II | Active |
| EasyTouch | 801607 | FDA UDI | Class II | Active |
| EasyTouch | 802107 | FDA UDI | Class II | Active |
| EasyTouch | 810001 | FDA UDI | Class I | Active |
| EasyTouch | 842531 | FDA UDI | Class II | Active |
| EasyTouch | 802709 | FDA UDI | Class II | Active |
| Kroger Healthpro | 909011 | FDA UDI | Class I | Active |
| EasyTouch | 812300 | FDA UDI | Class II | Active |
| EasyTouch | 811807 | FDA UDI | Class II | Active |
| EasyTouch | 802307 | FDA UDI | Class II | Active |
| EasyTouch | 812101 | FDA UDI | Class II | Active |
| BluLink | 849001 | FDA UDI | Class II | Active |
| EasyTouch | 823015 | FDA UDI | Class II | Active |
| EasyTouch | 802501 | FDA UDI | Class II | Active |
| EasyTouch | 830536 | FDA UDI | Class II | Active |
| EasyTouch | 830101 | FDA UDI | Class II | Active |
| EasyTouch | 872231 | FDA UDI | Class II | Active |
| EasyTouch | 825211 | FDA UDI | Class II | Active |
| EasyTouch | 802605 | FDA UDI | Class II | Active |
| HealthPro | 809001 | FDA UDI | Class II | Active |
| EasyTouch | 802201 | FDA UDI | Class II | Active |
| EasyTouch | 822610 | FDA UDI | Class II | Active |
| EasyTouch | 822505 | FDA UDI | Class II | Active |
Related Companies
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FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
MHC Medical Products has two FDA recall records, both initiated on April 6, 2018. One record remains open, while the other is classified. Both involve potential mislabeling of retail shelf cartons with incorrect lot numbers.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Apr 6, 2018 | Z-1780-2018 | — | open, classified | The retail shelf cartons may be labeled with an incorrect lot number. |
| Apr 6, 2018 | Z-1779-2018 | — | open, classified | The retail shelf cartons may be labeled with an incorrect lot number. |