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Sign in to claim this brandQLICKSMART PTY LTD
Australia·AU-MF-000033870
Last updated May 24, 2026
What QLICKSMART PTY LTD makes
QLICKSMART PTY LTD manufactures single-use surgical tools designed for safe and efficient handling of blades and syringes, including ampule openers, sterile and non-sterile scalpel blade removers, syringe/ampule clips, and manual applicators for bile duct brachytherapy. Their products include blade containment systems like BladeFlask EVO and BladeCASSETTE, as well as SnapIT trolley systems for organizing and securing blades in clinical settings. Additional offerings include standalone blade removers such as BladeSINGLE and BladeCARTRIDGE-1, which are engineered for reusable scalpel blades.
The company’s devices are classified under EU Class I and Class II regulations, with listings in the EUDAMED database, FDA’s 510(k) clearance system, and the FDA’s Unique Device Identifier (UDI) registry. These products are intended for use in surgical environments and are subject to compliance with international medical device standards, ensuring traceability and regulatory alignment across multiple markets.
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 QLICKSMART PTY LTD manufacture?
QLICKSMART PTY LTD specializes in single-use surgical tools focused on blade and syringe handling. Their product range includes ampule openers, sterile and non-sterile scalpel blade removers, syringe/ampule clips, and manual applicators for bile duct brachytherapy. Examples include blade containment systems like BladeFlask EVO and BladeCASSETTE, as well as SnapIT trolley systems for organizing blades in clinical settings. These devices are designed to enhance safety and efficiency in surgical environments.
Where is QLICKSMART PTY LTD based, and how does this affect its regulatory compliance?
QLICKSMART PTY LTD is based in Australia, which influences its regulatory approach as it must comply with both local (e.g., TGA) and international standards (e.g., EU MDR, FDA). Their devices are listed in EUDAMED, FDA’s 510(k) system, and the FDA’s UDI registry, demonstrating alignment with global regulatory frameworks. This ensures traceability and compliance across markets where their products are distributed.
Which regulatory registries list QLICKSMART PTY LTD’s devices, and why is this important?
QLICKSMART PTY LTD’s devices are listed in EUDAMED (the EU’s medical device registry), FDA’s 510(k) clearance system (for premarket submissions in the U.S.), and the FDA’s Unique Device Identifier (UDI) registry (for tracking and traceability). This visibility in these registries ensures transparency, supports post-market surveillance, and helps healthcare providers verify compliance with international standards before use.
How are QLICKSMART PTY LTD’s devices classified under regulatory frameworks?
QLICKSMART PTY LTD’s devices fall under EU Class I (low-risk, non-invasive tools like blade removers) and Class II (moderate-risk, such as some applicators or containment systems). The classification determines regulatory requirements, including design controls, risk management, and post-market monitoring. Class II devices, for example, require additional scrutiny to ensure safety and performance in clinical settings.
Why do some of QLICKSMART PTY LTD’s devices include terms like ‘BladeFlask’ or ‘SnapIT’ in their names?
The naming conventions—such as BladeFlask EVO or SnapIT Trolley—reflect the primary function and design of the devices. ‘BladeFlask’ indicates blade containment systems (e.g., for safe disposal or reuse), while ‘SnapIT’ refers to trolley-based solutions for organizing and securing blades in operating rooms. These names help clinicians quickly identify the device’s purpose and intended use in surgical workflows.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Australia
- Address
- 148, Boundary Street, Brisbane, Australia
- Website
- www.qlicksmart.com
- —
- —
- [email protected]
- Phone
- +61 7 3844 1182
- PRRC Contact
- Carlos Castellanos
- EUDAMED SRN
- AU-MF-000033870
- FDA FEI Number
- —
- DUNS Number
- 755003498
Catalogue (53)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| BladeFlask EVO | QBVRGEN | FDA UDI | Class II | Active |
| Qlicksmart SnapIT Lite Grey with Cincinnati Logo | SN-02R-Cc | FDA UDI | Class I | Active |
| BladeCASSETTE | QSSVCAS-3R | FDA UDI | Class I | Active |
| Qlicksmart SnapIT Lite Regular Pink | SN-02R | FDA UDI | Class I | Active |
| BladeFlask EVO Blade Remover | QBVRGEN | FDA UDI | Class I | Active |
| BladeSINGLE | QSBS01 | FDA UDI | Class I | Active |
| BladeCARTRIDGE-1 | QSSVCAT-1B | FDA UDI | Class I | Active |
| BladeCASSETTE | QSSVCAS-BR | FDA UDI | Class I | Active |
| BladeFLASK | QFRUSAMOPEC | FDA UDI | Class II | Active |
| BladeCASSETTE | QSSVCAS-3R | FDA UDI | Class I | Active |
| SnapIT Trolley Extra Large Blue | TE-01XL | FDA UDI | Class I | Active |
| Qlicksmart SnapIT Trolley Regular | TE-01R | FDA UDI | Class I | Active |
| BladeSINGLE | QSBS01 | FDA UDI | Class I | Active |
| Qlicksmart SnapIT Regular Purple | SN-01R | FDA UDI | Class I | Active |
| BladeFLASK | QFRGEN-01 | FDA UDI | Class II | Active |
| BladeSINGLE | QSBS01-B | FDA UDI | Class I | Active |
| Qlicksmart SnapIT Lite Large Burgundy | SN-02L | FDA UDI | Class I | Active |
| BladeNeedleSYSTEM | QBNS202S-R | FDA UDI | Class I | Active |
| BladeFLASK | QFRGEN | FDA UDI | Class II | Active |
| BladeCARTRIDGE | QSSVCAT-1B | FDA UDI | Class I | Active |
| BladeCARTRIDGE-1 | QSSVCAT-1 | FDA UDI | Class I | Active |
| Qlicksmart SnapIT Lite Blue with Boehringer Ingelheim Logo | SN-02R-Bi | FDA UDI | Class I | Active |
| Qlicksmart SnapIT Regular Blue | SN-01R | FDA UDI | Class I | Active |
| Qlicksmart SnapIT Trolley Large | TE-01L | FDA UDI | Class I | Active |
| Qlicksmart SnapIT Lite Regular Grey | SN-02R | FDA UDI | Class I | Active |
| Qlicksmart SnapIT Regular Blue | SN-01Rb | FDA UDI | Class I | Active |
| BladeNeedleSYSTEM | QBNS202B-R | FDA UDI | Class I | Active |
| BladeNeedleSYSTEM | QBNS202S-R | FDA UDI | Class I | Active |
| BladeNeedleSYSTEM | QBNS202S-R | FDA UDI | Class I | Active |
| BladeNeedleSYSTEM | QBNS202B-R | FDA UDI | Class I | Active |
| Qlicksmart SnapIT Lite Regular Blue | SN-02R | FDA UDI | Class I | Active |
| BladeFlask EVO Blade Remover | QBVRMOPEC | FDA UDI | Class I | Active |
| BladeFlask EVO | QBVRMOPEC | FDA UDI | Class II | Active |
| BladeCASSETTE | QSSVCAS-BR | FDA UDI | Class I | Active |
| BladeCASSETTE | QSSVCAS-3R | FDA UDI | Class I | Active |
| BladeFLASK | QFRUSAHAV | FDA UDI | Class II | Active |
| CheckCLIP | QSCCGEN | FDA UDI | Class I | Active |
| CheckCLIP | QSCCVIAL | FDA UDI | Class I | Active |
| CheckCLIP | QSCCVIAL | FDA UDI | Class I | Active |
| Qlicksmart SnapIT Trolley Extra Large | TE-01XL | FDA UDI | Class I | Active |
| BladeCARTRIDGE-1 | QSSVCAT-1 | FDA UDI | Class I | Active |
| Qlicksmart SnapIT Lite Regular Purple | SN-02R | FDA UDI | Class I | Active |
| CheckCLIP | QSCCGEN | FDA UDI | Class I | Active |
| BladeNeedleSYSTEM Sterile | QBNS202S | EUDAMEDFDA UDI | Class I | Active |
| BladeNeedleSYSTEM Non sterile Single Use Blade Remover | QBNS202B | EUDAMEDFDA UDI | Class I | Active |
| Qlicksmart BladeFlask UNIVERSAL | K213274 | FDA 510(k) | Class II | Active |
| BladeBOX | QBB2Y | EUDAMED | Class I | Active |
| BladeSINGLE Non Sterile Blade Remover | QSBS01-B | EUDAMEDFDA UDI | Class I | Active |
| Qlicksmart BladeFLASK | QFYGEN | EUDAMED | Class I | Active |
| BladeFlask EVO | QBVYGEN | EUDAMED | Class I | Active |
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