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Sign in to claim this brandWhat ADEPT MEDICAL LIMITED makes
Adept Medical Limited manufactures reusable operating and radiological patient positioning devices, including surgical instrument tables, operating tables, and arm/leg positioners for radiological procedures. Their portfolio also includes single-use surgical suction cannulas and tympanostomy tubes, with the NeoZoline brand covering multiple applications in these categories.
The company’s devices are classified under FDA’s Class I and Class II regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. Adept Medical Limited 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 Adept Medical Limited manufacture?
Adept Medical Limited produces a range of medical devices, including reusable operating and radiological patient positioning solutions such as surgical instrument tables, operating tables, and arm/leg positioners for radiological imaging. They also supply single-use surgical suction cannulas and tympanostomy tubes. The NeoZoline brand encompasses several of their products across these categories, covering both reusable and single-use applications.
Where is Adept Medical Limited based?
Adept Medical Limited is headquartered in the United States. The company’s location is relevant for understanding regulatory oversight and compliance, as it operates under the jurisdiction of the FDA.
Which regulatory registries list Adept Medical Limited’s devices?
Adept Medical Limited’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the medical device supply chain, allowing healthcare providers and regulators to verify device details and compliance.
How are Adept Medical Limited’s devices classified under FDA regulations?
Adept Medical Limited’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose the lowest risk and may require general controls, while Class II devices involve moderate risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential risks.
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
- 592534619
Catalogue (66)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| NeoZoline | NZ3122-2 | FDA UDI | Class II | Active |
| Adept Medical STARTable | AM0140C | FDA UDI | Class I | Unknown |
| NeoZoline | NZ3211-2 | FDA UDI | Class II | Active |
| NeoZoline | NZ3306 | FDA UDI | Class II | Active |
| STARSupport | NZ0130B | FDA UDI | Class I | Active |
| STARSupport | AM0130 | FDA UDI | Class I | Unknown |
| NeoZoline | NZ3123-2 | FDA UDI | Class II | Active |
| STARBoard with Extension | AM0180 | FDA UDI | Class I | Unknown |
| Micro Ear Suction Tube Multi Pack + Controller Pack | NZ3256Bent | FDA UDI | Class I | Active |
| Adept Medical STARSystem | AM0160C | FDA UDI | Class I | Unknown |
| NeoZoline | NZ3223Blue | FDA UDI | Class II | Active |
| NeoZoline | NZ3111-2 | FDA UDI | Class II | Active |
| Adept Medical STARBoard + Left Arm Support | AM0100D | FDA UDI | Class I | Unknown |
| NeoZoline | NZ3112-2 | FDA UDI | Class II | Active |
| Adept Medical STARBoard | AM0170B | FDA UDI | Class I | Active |
| Adept Medical Prone Head Support | A | FDA UDI | Class I | Active |
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