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Sign in to claim this brandAsmoh USA Inc
US
Last updated May 25, 2026
What Asmoh USA Inc makes
Asmoh USA Inc manufactures single-use hypodermic needles and metered-delivery hypodermic syringes designed for subcutaneous and intramuscular injections. These devices are intended for one-time use in clinical and home healthcare settings to deliver precise volumes of liquids, including medications and vaccines. The syringes feature calibrated markings to ensure accurate dosing, while the needles are engineered for minimal patient discomfort and reduced risk of accidental needlesticks. Both products are engineered for compatibility with standard injection techniques and pharmaceutical formulations.
The company’s devices fall under FDA Class II regulation, indicating they require special controls to ensure safety and effectiveness beyond general controls. All products are listed in the FDA’s Unique Device Identifier (UDI) database, enabling traceability and compliance tracking in healthcare systems. Asmoh USA Inc operates from the United States, adhering to domestic regulatory standards for medical device manufacturing and distribution.
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 Asmoh USA Inc manufacture?
Asmoh USA Inc specializes in single-use medical devices for injections. Specifically, they produce hypodermic needles and metered-delivery hypodermic syringes. These devices are designed for subcutaneous and intramuscular injections in clinical and home healthcare settings. The syringes include calibrated markings to ensure precise dosing, while the needles are engineered to minimize patient discomfort and reduce needlestick risks.
Where is Asmoh USA Inc based, and what regulatory standards does it follow?
Asmoh USA Inc is based in the United States. Since its devices are manufactured domestically, they adhere to U.S. regulatory standards for medical devices, including those set by the FDA. The company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, which supports traceability and compliance tracking in healthcare environments.
Which regulatory registries or databases list Asmoh USA Inc’s devices?
Asmoh USA Inc’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures that healthcare providers and systems can track and verify the devices’ compliance and traceability, which is essential for safety and quality control in medical settings.
How are Asmoh USA Inc’s devices classified by regulatory authorities?
Asmoh USA Inc’s devices are classified as FDA Class II. This classification means they require special controls beyond general controls to ensure their safety and effectiveness. Class II devices typically involve moderate risk and require additional testing, labeling, or post-market surveillance to mitigate potential hazards.
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
- 125843506
Catalogue (12)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Asmoh | SYRINGE 10CC L/LOCK W/O NEEDLE | FDA UDI | Class II | Active |
| Asmoh | SYRINGE 3CC SAFETY NEEDLE 22G X 1 1/2", LUER LOCK | FDA UDI | Class II | Active |
| Asmoh | SYRINGE 5CC L/LOCK W/O NEEDLE | FDA UDI | Class II | Active |
| Asmoh | SYRINGE 5CC SAFETY NEEDLE 22G X 1 1/2", LUER LOCK | FDA UDI | Class II | Active |
| Asmoh | SYRINGE 1CC SAFETY NEEDLE 25G X 5/8" | FDA UDI | Class II | Active |
| Asmoh | SYRINGE 3CC SAFETY NEEDLE 22G X 1 1/2", LUER LOCK | FDA UDI | Class II | Active |
| Asmoh | SYRINGE 5CC SAFETY NEEDLE 21G X 1 1/2", LUER LOCK | FDA UDI | Class II | Active |
| Asmoh | SYRINGE 60CC L/LOCK W/O NEEDLE | FDA UDI | Class II | Active |
| Asmoh | SYRINGE 3CC L/LOCK W/O NEEDLE | FDA UDI | Class II | Active |
| Asmoh | SYRINGE 20CC L/LOCK W/O NEEDLE | FDA UDI | Class II | Active |
| Asmoh | SYRINGE 10CC SAFETY NEEDLE 21G X 1 1/2", LUER LOCK | FDA UDI | Class II | Active |
| Asmoh | SYRINGE 30CC L/LOCK W/O NEEDLE | FDA UDI | Class II | Active |
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