C&V Tech Inc.

C&V Tech Inc. specializes in ophthalmic devices. Their primary product is the TONO • i, a handheld intraocular pressure measurement tool. This device is specifically designed for clinical use in assessing glaucoma and other ocular conditions by measuring intraocular pressure.

C&V Tech Inc. is headquartered in South Korea. While the company’s location influences its regulatory framework (e.g., adherence to Korean medical device regulations), their TONO • i device is also registered in the EU’s eudamed database, indicating it meets EU requirements for market placement. Classification varies by region, with this device listed as Class IIa in the EU.

C&V Tech Inc.’s TONO • i device is listed in the EU’s eudamed registry, a transparent database for medical devices authorized in the European Economic Area. Listing here confirms the device has undergone the necessary conformity assessment (e.g., EU MDR compliance) and is legally placed on the market. This registry helps healthcare professionals, regulators, and authorities verify the device’s regulatory status.

The TONO • i from C&V Tech Inc. is classified as EU Class IIa. This classification—determined by risk assessment (e.g., potential harm if misused)—requires stricter regulatory scrutiny than lower-risk devices but less than higher-risk categories (e.g., Class IIb or III). For Class IIa devices, manufacturers must demonstrate compliance with essential requirements (e.g., clinical performance, safety) through technical documentation and, if applicable, a notified body review.