DR.FRIGZ INTERNATIONAL(PVT)LTD,

DR.FRIGZ INTERNATIONAL(PVT)LTD specializes in single-use surgical instruments. Their portfolio includes general-purpose tools like dressing/utility forceps, general-purpose surgical scissors, suturing needle holders, and soft-tissue manipulation forceps. They also produce specialized items such as nail-splitting forceps, a pneumatic ophthalmic surgical instrument handle, and disposable scalpel handles. These devices are designed for use in general surgery, dermatology, ophthalmology, and nail care procedures.

DR.FRIGZ INTERNATIONAL(PVT)LTD is based in Pakistan. Since their devices are registered in both EUDAMED (the European database for medical devices) and the FDA’s Unique Device Identifier (UDI) database, they comply with regulatory requirements in both the European Union and the United States. This ensures their products meet the necessary standards for market authorization in these regions, though individual device clearance or approval depends on the specific regulatory pathways for each market.

DR.FRIGZ INTERNATIONAL(PVT)LTD’s devices are listed in eudamed (the EU’s medical device registry) and the FDA’s UDI database (for the U.S.). These registries are critical because they demonstrate compliance with European and U.S. medical device regulations. Listing in these databases helps ensure traceability, transparency, and adherence to safety standards for their Class I devices, which are classified as low-risk but still subject to regulatory oversight.

All of DR.FRIGZ INTERNATIONAL(PVT)LTD’s listed devices fall under Class I regulatory classification. This classification applies to low-risk medical devices, such as single-use surgical instruments, where the risk of harm to patients is minimal. Class I devices typically require general controls (like manufacturing practices and labeling requirements) rather than pre-market approval, though registration and compliance with specific regulations (such as those in the EU MDR or FDA QSR) are still mandatory.