Company: APXIF
Filing Date: 2025-06-13
Form Type: F-4/A
Source: 0001213900-25-054324
Chunk: 384

Company: APx Acquisition Corp. I
Filing Date: 2025-06-13
Form: F-4/A
Chunk 384
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AS and EMQN certificates. As such, we maintain the highest standards to comply with all requirements. We are subject to survey and inspection every year to assess compliance with CAP’s and EMQN’s program standards, and we may be subject to additional unannounced inspections. Additionally, our laboratory operations, for both Rewell and Heritas Diagnostics’ products, are certified under the ISO 9001:2015 standard, a testament to commitment to quality management. This certification underscores our commitment to consistent, high -qualityprocesses and procedures that enhance customer satisfaction and operational efficiency. It is an integral part of our quality assurance program, ensuring that every aspect of our service adheres to international best practices and continual improvement strategies. This ISO certification, which is also subject to survey and inspection every year, aligns with our overarching mission to deliver exceptional genetic testing services and to foster trust and reliability in the global healthcare landscape. 192 Regulations Applicable to our Products and Services Rewell and Heritas Diagnostics Tests We have developed our products as LDTs, which are a type of in vitro diagnostic test that is designed, manufactured, and used within a laboratory. LDTs are developed under the complexity and uniqueness of a laboratory’s specific needs, which allows us to offer tests with unique conditions, develop tests using new technologies, or respond to market health needs that traditional commercial tests do not address. All our products and services fall under the category of LDTs, reflecting our capacity to develop specialized diagnostics tailored to the unique needs of our customers. These proprietary tests are a cornerstone of our service offering, enabling us to deliver personalized insights into individual health concerns, particularly in areas where commercial testing options are limited or non -existent. Responsibility for ensuring compliance with legal standards lies with the laboratory conducting the test and the authorized professionals signing the results. Specifically, in Argentina and Mexico, the responsible professional must be a licensed biochemist, who is authorized to sign -offon laboratory results from LDTs, ensuring compliance with local professional and healthcare regulations. The Company, in turn, guarantees that each partner laboratory complies with the necessary legal authorizations, including facility and professional certifications, to perform these tests in accordance with local regulations. As of the date of this Registration Statement of which this prospectus forms part, there are no regulatory approvals for LDTs required by Argentine and Mexican law, and we have not sought any such approvals. In Argentina, Mexico, and Paraguay, our main target markets in the short -term, regulatory oversight of LDTs varies