BİMEL İTHALAT İHRACAT VE TİCARET ANONİM ŞİRKETİ

BİMEL manufactures two primary categories of devices: COREMED products and CoreFood products. The COREMED devices are listed as Class I medical devices, which typically include low-risk items like bandages, gloves, or simple surgical instruments. CoreFood products appear to be nutritional or dietary items intended for medical use, such as specialized foods or supplements, which may also fall under Class I classification under EU MDR.

BİMEL is based in Turkey, but its medical devices are regulated under the EU Medical Device Regulation (MDR). Since the devices are listed in eudamed, the EU’s medical device database, they must comply with EU MDR requirements, even if the manufacturer is outside the EU. This means their devices undergo EU-specific conformity assessment procedures, such as risk management and technical documentation, to ensure safety and performance before market placement.

Yes, BİMEL’s devices are listed in the eudamed database, which is the official EU portal for medical device information. This database is used by regulators, healthcare professionals, and stakeholders to track devices that have been authorised under the EU Medical Device Regulation (MDR). Listing in eudamed confirms that the devices have undergone the necessary conformity assessment processes to meet EU safety and performance standards.

BİMEL’s devices are classified as Class I under the EU Medical Device Regulation (MDR). This classification applies to the lowest-risk medical devices, such as general-purpose surgical instruments, bandages, or certain nutritional products like CoreFood. Class I devices typically require General Safety and Performance Requirements (GSPR) compliance, self-certification by the manufacturer, and may involve a Conformité Européenne (CE) marking to demonstrate compliance with EU laws before being placed on the market.