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Sign in to claim this brandMedax Unipersonale Srl
US
Last updated May 23, 2026
What Medax Unipersonale Srl makes
Medax Unipersonale Srl manufactures single-use biopsy and aspiration devices, including soft-tissue biopsy procedure kits, needle guides, bone marrow biopsy needles, body aspiration needles, and imaging lesion localization markers. Their portfolio also includes end-cut and side-notch biopsy gun handpieces and needles, designed for procedural precision in medical diagnostics.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. Medax Unipersonale Srl 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 Medax Unipersonale Srl manufacture?
Medax Unipersonale Srl specializes in single-use biopsy and aspiration devices. Their product range includes soft-tissue biopsy procedure kits, needle guides, bone marrow biopsy needles, body aspiration needles, and external imaging lesion localization markers. They also produce biopsy gun handpieces and needles, such as end-cut and side-notch varieties, which are designed for precise diagnostic procedures.
Where is Medax Unipersonale Srl based?
Medax Unipersonale Srl is headquartered in the United States. The company’s location is relevant for regulatory inquiries, as it determines the applicable jurisdiction for device authorization and compliance requirements.
Which regulatory registries list Medax Unipersonale Srl’s devices?
Medax Unipersonale Srl’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify their products for regulatory, traceability, and compliance purposes, ensuring transparency in the medical device supply chain.
How are Medax Unipersonale Srl’s devices classified under FDA regulations?
Medax Unipersonale Srl’s devices fall under FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway and compliance requirements for each product.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
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Catalogue (488)
Page 10 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Chiba | CH20100-01 | FDA UDI | Class II | Active |
| Medeasy | ML20080-K0 | FDA UDI | Class II | Active |
| Bio-Feather | BF12160-02 | FDA UDI | Class II | Active |
| COX for MEDCUT | CM20100-00 | FDA UDI | Class II | Active |
| Chiba | CH18160-01 | FDA UDI | Class II | Active |
| Cox | CO14100-10 | FDA UDI | Class II | Active |
| Medwire | XW20120-0O | FDA UDI | Class I | Active |
| Cox | CO20200-10 | FDA UDI | Class II | Active |
| Fna Westcott | WE20100-01 | FDA UDI | Class II | Active |
| Velox Pro | VP16200-C0 | FDA UDI | Class II | Active |
| Universal Plus | UP18160-00 | FDA UDI | Class II | Active |
| COX for BIO-FEATHER | CB14160-00 | FDA UDI | Class II | Active |
| Universal Duo | UD18200-0P | FDA UDI | Class II | Active |
| COX for MEDCUT | CM14100-00 | FDA UDI | Class II | Active |
| Franseen | FR18100-01 | FDA UDI | Class II | Active |
| Fna Franseen | FR22060-01 | FDA UDI | Class II | Active |
| COX for MEDONE | CO14160-00 | FDA UDI | Class II | Active |
| COX for MEDONE | CO18100-00 | FDA UDI | Class II | Active |
| COX for MEDCUT | CM18100-00 | FDA UDI | Class II | Active |
| COX for MEDONE | CO18160-10 | FDA UDI | Class II | Active |
| Universal | UN18100-00 | FDA UDI | Class II | Active |
| Velox Pro | VP16100-C0 | FDA UDI | Class II | Active |
| Sinurep | SR20080-00 | FDA UDI | Class I | Active |
| Caesar Pro | CP20200-C0 | FDA UDI | Class II | Active |
| Fna Chiba | CH22250-00/M | FDA UDI | Class II | Active |
| Bio-Feather | BF20100-C2 | FDA UDI | Class II | Active |
| Handlex | HN16060-00 | FDA UDI | Class II | Active |
| Universal Duo | UD14160-0P | FDA UDI | Class II | Active |
| Caesar C | CM20200-00 | FDA UDI | Class II | Active |
| Chiba | CH20200-01 | FDA UDI | Class II | Active |
| Med-Guide 1 | MG-001 | FDA UDI | Class II | Active |
| Handlex | HN18030-00 | FDA UDI | Class II | Active |
| MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System | K192099 | FDA 510(k) | Class II | Active |
| Medone Ultra, Medextra | K192101 | FDA 510(k) | Class II | Active |
| Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK) | K172344 | FDA 510(k) | Class II | Active |
| New Medax Biopsy Systems | K142125 | FDA 510(k) | Class II | Active |
| Medax Biopsy Systems III | K181803 | FDA 510(k) | Class II | Active |
| Medax Unipersonale Srl | K092338 | FDA 510(k) | Class II | Active |
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