Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Pikdare Spa
Identity
- Trade Name
- Insupen ADVANCED EUDAMED
- Model / Reference
- PEN NEEDLE EUDAMED02002263040030 EUDAMED02002263000080 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18058090052880 EUDAMED18058090016578 EUDAMED
- Basic UDI-DI
- 8058090PN310000ES EUDAMED
- 510(k) Number
- K203792 FDA 510(k)
- FDA Product Code
- FMI FDA 510(k)
- EMDN Code
- A0101010202 HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5570 FDA 510(k)
- Regulation Number
- 880.5570 FDA 510(k)
- Market of Registration
- Italy EUDAMED
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
Yes
Measuring Function
No
Incorporates Medicinal Product
No
The Insupen Pen Needle is a sterile, disposable insulin pen needle designed for subcutaneous administration of insulin via pen injector devices. These needles are categorized under the product code FMI and are engineered to minimize injection pain through features such as triple-sharpened tips and proprietary lubrication processes. Available in multiple lengths and diameters, they adhere to principles aimed at enhancing patient comfort during insulin therapy. The device is intended exclusively for single-use applications in general hospital settings.
Insupen Pen Needles are supplied as sterile, single-use items and must not be reused. They are authorized under FDA 510(k) clearance (K203792) and comply with the Medical Device Regulation (MDR). The needles are packaged individually and require no special storage conditions beyond protection from physical damage and contamination. No MRI safety information is specified, and the device is not intended for reusable applications or alternative clinical settings.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Insupen Advanced - Pic Solution, Insupen Original - picsolution.com, Insupen® Pen Needles - Droplet Micron, Pen Needles - Insupen Original - Spirit Health
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K203792 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pikdare Spa
Sources (3)
- FDA 510(k) K203792 24 fields · synced Oct 6, 2026
- EUDAMED 19c237ae-9a07-4811-bcfa-ee9811e41ea0 61 fields · synced Jul 8, 2026
- EUDAMED cc52ac90-d2ad-4fa1-87f6-da013208ff14 61 fields · synced Sep 30, 2026