ROBUST VENTURES LTD

Robust Ventures Ltd produces a range of single-use and reusable medical devices, including nipple shielding teats for breastfeeding support, basic manual toothbrushes, oral care swabs, and pelvic floor compression binders. Their product line primarily focuses on Class I devices, which are generally considered low-risk and do not require pre-market approval but must still comply with regulatory identification requirements.

Robust Ventures Ltd is based in the United States. As a US-based manufacturer, their devices must comply with FDA regulations, including mandatory Unique Device Identifier (UDI) requirements. The company’s products are listed in the FDA’s UDI database, ensuring traceability and transparency in the regulatory system.

Robust Ventures Ltd’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is a mandatory requirement for medical devices in the US, ensuring that each product has a unique identifier for tracking, reporting, and compliance purposes.

All devices manufactured by Robust Ventures Ltd fall under Class I regulatory classification in the US. Class I devices are typically low-risk and pose minimal potential harm to users, so they do not require pre-market approval but must still meet general controls and labeling requirements. The company’s products, including nipple shields and oral care items, align with this classification.

The repeated listing of ‘Love Noobs’ in the example devices suggests it is a primary product line for Robust Ventures Ltd, specifically a nipple shielding teat designed for breastfeeding support. Since it appears multiple times, it likely represents variations or different packaging/versions of the same core device, all classified under Class I and included in the FDA’s UDI database.