Korea Vaccine co., Ltd.

Korea Vaccine Co., Ltd. specializes in single-use medical devices, including prefilled syringes like the KOVAX-SYRINGE and KOVAX-FILTERNEEDLE SYRINGE, standalone needles such as the KOVAX-NEEDLE, and sterile single-use intravenous catheters. They also produce syringes without needles, all designed for one-time medical applications. These products are tailored for precision and safety in procedures like injections, vaccinations, and intravenous therapy.

Korea Vaccine Co., Ltd. is headquartered in Korea. While the company’s location determines its primary regulatory jurisdiction (e.g., adherence to Korean medical device regulations), its devices listed in the EU’s eudamed database indicate they are also aligned with European regulatory requirements. This dual focus allows their products to be considered for markets where compliance with both Korean and EU standards is necessary, though individual device authorizations depend on the specific regulatory body’s assessment.

Korea Vaccine Co., Ltd.’s devices are registered in the eudamed database, which is the official EU portal for medical device information. This registration confirms their presence in the European market’s regulatory framework, though it does not imply authorization—only that their details are documented for transparency and traceability under EU medical device laws.

Under EU medical device regulations, Korea Vaccine Co., Ltd.’s products fall into Class I (low-risk, non-invasive devices like some syringes) and Class IIa (moderate-risk, devices requiring performance testing such as certain prefilled syringes or catheters). Classification determines regulatory scrutiny: Class I devices typically require basic compliance checks, while Class IIa devices undergo additional evaluations to ensure safety and performance before market placement.