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Sign in to claim this brandABM ITALIA SPA
US
Last updated May 23, 2026
What ABM ITALIA SPA makes
ABM Italia SPA manufactures sharps disposal containers designed for the safe collection and disposal of used needles, syringes, and other contaminated sharp medical instruments. These containers are engineered to prevent accidental punctures and leaks, ensuring compliance with clinical waste handling protocols in healthcare settings.
The company’s sharps containers are classified as Class II medical devices under FDA regulations and are listed in the FDA’s Unique Device Identification (UDI) system. The products are intended for use within the United States, adhering to applicable safety and performance standards for sharps disposal solutions.
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 ABM Italia SPA primarily manufacture?
ABM Italia SPA specializes in manufacturing sharps disposal containers. These devices are specifically designed for safely collecting and disposing of used needles, syringes, and other contaminated sharp medical instruments in healthcare environments. The focus is on preventing accidental punctures and leaks, which aligns with strict clinical waste handling requirements.
Where is ABM Italia SPA based, and what regulatory region does it serve?
ABM Italia SPA is based in the United States. Its devices are intended for use within this regulatory region, where they must comply with applicable safety and performance standards, including those set by the FDA.
How are ABM Italia SPA’s devices classified under FDA regulations?
ABM Italia SPA’s sharps disposal containers are classified as Class II medical devices under FDA regulations. This classification is typically assigned to devices that pose moderate risk and require special controls beyond general controls to ensure their safety and effectiveness.
Are ABM Italia SPA’s devices listed in any regulatory registries?
Yes, ABM Italia SPA’s devices are listed in the FDA’s Unique Device Identification (UDI) system. This registry helps track and identify medical devices throughout their lifecycle, ensuring transparency and traceability in compliance with regulatory requirements.
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
- 338493631
Catalogue (92)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| APmedical | FGPBS0.8RS001 PBS 0.8R | FDA UDI | Class II | Active |
| APmedical | FGCS4R001 CS 4R | FDA UDI | Class II | Active |
| APmedical | FGAP50MYS001 AP50MY | FDA UDI | Class II | Active |
| APmedical | FGSC30DYC001 SC30DY | FDA UDI | Class II | Active |
| APmedical | FGAP50DRS001 AP50DR | FDA UDI | Class II | Active |
| APmedical | FGAP60MYC001 AP60MY | FDA UDI | Class II | Active |
| APmedical | FGAP5Q4YS001 AP5.4Y | FDA UDI | Class II | Active |
| APmedical | FGPBS12RS001 PBS 12R | FDA UDI | Class II | Active |
| APmedical | FGCS4RS001 CS 4R | FDA UDI | Class II | Active |
| APmedical | FGCS5BYS001 CS 5BY | FDA UDI | Class II | Active |
| APmedical | FGAP50DBC001 AP50DB | FDA UDI | Class II | Active |
| APmedical | FGCS3R001 CS 3R | FDA UDI | Class II | Active |
| APmedical | FGAP30MRS001 AP30MR | FDA UDI | Class II | Active |
| APmedical | FGAP30DBS001 AP30DB | FDA UDI | Class II | Active |
| APmedical | FGAP30DWS001 AP30DW | FDA UDI | Class II | Active |
| APmedical | FGPBS12Y001 PBS 12Y | FDA UDI | Class II | Active |
| APmedical | FGPBS7R001 PBS 7R | FDA UDI | Class II | Active |
| APmedical | FGPBS12YS001 PBS 12Y | FDA UDI | Class II | Active |
| APmedical | FGAP50MRC001 AP50MR | FDA UDI | Class II | Active |
| APmedical | FGAP50DRC001 AP50DR | FDA UDI | Class II | Active |
| APmedical | FGPBS7Y001 PBS 7Y | FDA UDI | Class II | Active |
| APmedical | FGPBS2RS001 PBS 2R | FDA UDI | Class II | Active |
| APmedical | FGAP30DWC001 AP30DW | FDA UDI | Class II | Active |
| APmedical | FGCS5BRS001 CS 5BR | FDA UDI | Class II | Active |
| APmedical | FGAP5Q4YC001 AP5.4Y | FDA UDI | Class II | Active |
| APmedical | FGCS3RS001 CS 3R | FDA UDI | Class II | Active |
| APmedical | FGPBS1.5Y001 PBS 1.5Y | FDA UDI | Class II | Active |
| APmedical | FGPBS1.5RS001 PBS 1.5R | FDA UDI | Class II | Active |
| APmedical | FGCS5BR001 CS 5BR | FDA UDI | Class II | Active |
| APmedical | FGAP5Q4RC001 AP5.4R | FDA UDI | Class II | Active |
| APmedical | FGPBS2YS001 PBS 2Y | FDA UDI | Class II | Active |
| APmedical | FGCS3YS001 CS 3Y | FDA UDI | Class II | Active |
| APmedical | FGAP50DBS001 AP50DB | FDA UDI | Class II | Active |
| APmedical | FGAP60DYS001 AP60DY | FDA UDI | Class II | Active |
| APmedical | FGAP30DRC001 AP30DR | FDA UDI | Class II | Active |
| APmedical | FGAP60DRS001 AP60DR | FDA UDI | Class II | Active |
| APmedical | FGAP50MYC001 AP50MY | FDA UDI | Class II | Active |
| APmedical | FGAP30DYS001 AP30DY | FDA UDI | Class II | Active |
| APmedical | FGAP30MBC001 AP30MB | FDA UDI | Class II | Active |
| APmedical | FGAP5Q4BS001 AP5.4B | FDA UDI | Class II | Active |
| APmedical | FGPBS0.8YS001 PBS 0.8Y | FDA UDI | Class II | Active |
| APmedical | FGPBS7RS001 PBS 7R | FDA UDI | Class II | Active |
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