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Sign in to claim this brandPIKDARE SPA
US
Last updated May 24, 2026
What PIKDARE SPA makes
PIKDARE SPA manufactures single-use hypodermic needles and autoinjector needles, including variants designed for safety and ease of use in medical injections. Their portfolio includes devices like the DropSafe Sicura and PIC INSUPEN series, which are intended for subcutaneous and intramuscular administration.
These products are classified as Class II medical devices and are authorised via FDA pathways, including 510(k) and UDI registrations. The company operates from the US and maintains listings under these regulatory frameworks.
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 PIKDARE SPA manufacture?
PIKDARE SPA specialises in single-use medical devices, specifically hypodermic needles and autoinjector needles. Their portfolio includes standard hypodermic needles as well as safety-focused variants, such as the DropSafe Sicura series and the PIC INSUPEN series, which are designed for subcutaneous and intramuscular injections. These devices are engineered to enhance usability and safety in clinical settings.
Where is PIKDARE SPA based, and what regulatory frameworks do they operate under?
PIKDARE SPA is based in the US. Their devices are authorised through FDA pathways, including the 510(k) premarket notification process and UDI (Unique Device Identification) registrations. These frameworks ensure compliance with US regulatory requirements for medical devices.
How are the devices manufactured by PIKDARE SPA classified under medical device regulations?
The devices produced by PIKDARE SPA are classified as Class II medical devices. This classification is determined by the FDA based on factors like the risk associated with the device’s use, intended purpose, and potential for harm if misused. Class II devices generally require special controls in addition to general controls to ensure safety and effectiveness.
Which regulatory registries or databases list PIKDARE SPA’s devices?
PIKDARE SPA’s devices are listed in the FDA’s 510(k) premarket notification database and the UDI (Unique Device Identification) system. These registries track authorised medical devices in the US, ensuring transparency and compliance with regulatory requirements for manufacturers and healthcare providers.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- htl-strefa.com
- —
- —
- [email protected]
- Phone
- 1-877-660-1900
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 437816603
Catalogue (32)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| DropSafe Sicura | 02099940210250 | FDA UDI | Class II | Active |
| Pic Insupen Original | 02022990030100 | FDA UDI | Class II | Active |
| Pic Insupen | 02022988000070 | FDA UDI | Class II | Active |
| DropSafe Sicura | 02099940250250 | FDA UDI | Class II | Active |
| DropSafe Sicura | 02094000270130 | FDA UDI | Class II | Active |
| Pic Insupen | 02022989000070 | FDA UDI | Class II | Active |
| Pic Insupen Original | 02022902030100 | FDA UDI | Class II | Active |
| DropSafe Sicura | 02099940180250 | FDA UDI | Class II | Active |
| DropSafe Sicura | 02099940270130 | FDA UDI | Class II | Active |
| Pic Insupen | 02022990000070 | FDA UDI | Class II | Active |
| DropSafe Sicura | 02094000220250 | FDA UDI | Class II | Active |
| DropSafe Sicura | 02094000250160 | FDA UDI | Class II | Active |
| Pic Insupen Original | 02002262030100 | FDA UDI | Class II | Active |
| DropSafe Sicura | 02099940230250 | FDA UDI | Class II | Active |
| Pic Insupen | 02022902000040 | FDA UDI | Class II | Active |
| DropSafe Sicura | 02099940220250 | FDA UDI | Class II | Active |
| DropSafe Sicura | 02094000210250 | FDA UDI | Class II | Active |
| Pic Insupen | 02002262000040 | FDA UDI | Class II | Active |
| DropSafe Sicura | 02094000180250 | FDA UDI | Class II | Active |
| Droplet | 02022987000100 | EUDAMEDFDA UDI | Class II | Active |
| Pic Insupen | 02022983000040 | FDA UDI | Class II | Active |
| Pic Insupen | 02002264000040 | FDA UDI | Class II | Active |
| DropSafe Sicura | 02094000300130 | FDA UDI | Class II | Active |
| DropSafe Sicura | 02094000250250 | FDA UDI | Class II | Active |
| Pic Insupen | 02022987000040 | FDA UDI | Class II | Active |
| DropSafe Sicura | 02094000230250 | FDA UDI | Class II | Active |
| Pic Insupen | 02002266010040 | FDA UDI | Class II | Active |
| Pic Insupen | 02022984000040 | FDA UDI | Class II | Active |
| DropSafe Sicura | 02099940250160 | FDA UDI | Class II | Active |
| DropSafe Sicura | 02099940300130 | FDA UDI | Class II | Active |
| DropSafeTM SicuraTM | K223353 | FDA 510(k) | Class II | Active |
| Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle | K203792 | EUDAMEDFDA 510(k) | Class II | Active |
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