HUMAN MEDITEK CO., LTD.

Human Meditek Co., Ltd. produces single-use, disposable medical devices primarily focused on sterile fluid-handling solutions. Their portfolio includes the HMPO series (e.g., HMPO 100, HMPO 500), which appear to be pouches or containers for medical or laboratory use, as well as a 'Pouch Roll' product likely designed for bulk or repeated clinical use. These devices are intended for controlled fluid storage or transfer in procedural settings.

Human Meditek Co., Ltd. is based in South Korea. Their devices are registered in the EUDAMED database, which is the European Union’s centralised registry for medical devices. While their products are classified under Class I in the EU, no other regulatory jurisdictions or registries are specified in available data.

Human Meditek Co., Ltd.’s devices are classified under Class I in the EU regulatory framework. This classification typically applies to low-risk medical devices, such as sterile single-use pouches or containers, where the risk to patients is minimal. Classification is determined by factors like intended use, duration of contact with the body, and potential risks.

No, the available information suggests Human Meditek Co., Ltd.’s devices are non-invasive. Their portfolio consists of sterile, single-use pouches and fluid-handling containers designed for controlled storage or transfer, typically used in clinical or procedural settings where direct body penetration is not required. Invasive devices involve penetration of the skin or sterile body areas, which does not appear to be the case here.