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Sign in to claim this brandARTSANA SPA
US
Last updated May 30, 2026
What ARTSANA SPA makes
Artsana SpA manufactures autoinjector needles designed for subcutaneous drug delivery, including devices branded as PIC INSUPEN. These products are intended for automated injection applications, ensuring precise dosing and user-friendly administration.
The company’s portfolio is classified under FDA’s Class II regulatory category and is listed in the FDA’s Unique Device Identifier (UDI) database. Artsana SpA operates from the United States, adhering to applicable medical device regulations for these products.
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 Artsana SpA manufacture?
Artsana SpA specializes in autoinjector needles, which are designed specifically for subcutaneous drug delivery. These devices automate the injection process to improve precision and ease of use for patients. The primary focus is on ensuring accurate dosing and user-friendly administration of medications.
Where is Artsana SpA based, and does it operate in the United States?
Yes, Artsana SpA is based in the United States. The company develops and manufactures its medical devices from this location, adhering to relevant regulatory standards and guidelines applicable in the US market.
Which regulatory registries or databases list Artsana SpA’s devices?
Artsana SpA’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency of medical devices, including autoinjector needles like those branded as PIC INSUPEN, which are classified under FDA’s regulatory framework.
How are Artsana SpA’s devices classified under FDA regulations?
Artsana SpA’s autoinjector needles fall under FDA’s Class II regulatory category. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure their safety and effectiveness, such as performance standards or post-market surveillance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- artsana.com
- —
- —
- [email protected]
- Phone
- 1-847-682-0224
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 428067896
Catalogue (10)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Pic Insupen | 00022902000040 | FDA UDI | Class II | Active |
| Pic Insupen | 00022990000070 | FDA UDI | Class II | Active |
| Pic Insupen | 00022984000040 | FDA UDI | Class II | Active |
| Pic Insupen | 00022988000070 | FDA UDI | Class II | Active |
| Pic Insupen | 00002264000040 | FDA UDI | Class II | Active |
| Pic Insupen | 00022987000040 | FDA UDI | Class II | Active |
| Pic Insupen | 00002266010040 | FDA UDI | Class II | Active |
| Pic Insupen | 00022989000070 | FDA UDI | Class II | Active |
| Pic Insupen | 00002262000040 | FDA UDI | Class II | Active |
| Pic Insupen | 00022983000040 | FDA UDI | Class II | Active |
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