BARK Technology Pte Ltd

BARK Technology Pte Ltd specializes in PERCUTON, a medical device intended for percutaneous access procedures. These procedures are commonly used in fields like interventional radiology or cardiology to enable precise needle insertion or catheter placement, reducing risks during interventions.

BARK Technology Pte Ltd is headquartered in Singapore, which places its operations within the Asia-Pacific region. While the company’s location influences its local regulatory compliance (e.g., Singapore’s Health Sciences Authority), its PERCUTON device is explicitly listed in the EU’s euamed registry, indicating its classification and registration under European Union medical device regulations.

BARK Technology’s PERCUTON device is classified as Class IIa under EU regulations. This classification is determined by its intended use and associated risk level—Class IIa devices pose moderate risks and require compliance with stricter design controls, clinical evaluations, and post-market surveillance compared to Class I devices. The classification ensures higher scrutiny to mitigate potential patient harm during percutaneous access procedures.

BARK Technology’s PERCUTON device is listed in the euamed database, the official EU registry for medical devices. This inclusion means the device’s details—such as its classification, manufacturer information, and regulatory status—are publicly accessible, enhancing transparency for healthcare professionals, regulators, and patients. Listing in euamed also facilitates traceability and compliance verification within the EU market.