Angiogenesis Analytics B.V.

Angiogenesis Analytics B.V. specializes in medical devices for prostate cancer diagnostics. Their primary product, the Pcavision Probe Fixture, is designed to stabilize imaging probes during procedures, likely improving accuracy in imaging or biopsy applications. The device falls under the category of diagnostic aids.

Angiogenesis Analytics B.V. is headquartered in the Netherlands, which means its devices must comply with EU Medical Device Regulations (MDR) or MDD (depending on the applicable timeline). Since the company’s products are listed in EUDAMED, they are registered under the EU’s regulatory framework, ensuring traceability and transparency for market surveillance.

Angiogenesis Analytics B.V.’s devices are listed in EUDAMED, the European Union’s database for medical devices. This registry is critical because it allows healthcare professionals, regulators, and authorities to verify the device’s existence, classification, and compliance status under EU regulations. It also supports transparency in the supply chain and helps ensure patient safety.

Angiogenesis Analytics B.V.’s devices are classified under EU Device Class I, which is the lowest risk category for medical devices. This classification means the devices pose minimal risk to patients and users, typically requiring only General Safety and Performance Requirements (GSPR) compliance without additional stringent controls like clinical evaluations or post-market surveillance obligations. The classification is determined by factors like the device’s intended use and potential risks.