CE Marking (EU MDR 2017/745)

• Device Class: I (Self‑certified)

• Intended Use Statement:

Melonga is intended to provide therapeutic techniques and exercises based on evidence-based psychoeducational and behavioral treatment methods appropriate for premature ejaculation patients of at least 18 years of age to assist them in managing their ejaculatory function. Melonga is intended for stand-alone use or as an adjunct to usual care to expand the psychosexual therapy options. The program may be used for a period of 12 weeks. Melonga is not intended to replace treatment by a healthcare provider, nor is it intended to provide information for diagnostic or therapeutic decisions.

• Applicable medical indications: Premature Ejaculation (ICD-10-CM: F52.4) ; Male Early Ejaculation (ICD-11: HA03.0)

• Compliant Territories:

  • Germany 🇩🇪

  • Austria 🇦🇹

  • Belgium (German‑speaking regions) 🇧🇪

  • Ireland 🇮🇪

  • Luxembourg 🇱🇺

  • Liechtenstein 🇱🇮

ISO 13485:2016 (maintained)

• As a ISO 13485:2016 compliant entity, we have a robust medical device quality management system (QMS) covering design, development, production, and post‑market surveillance.

Full Technical Documentation is available to regulatory authorities and upon request from healthcare professionals (email: compliance@melonga.com).

GDPR (EU 2016/679)

• Data Controller: Prognoix Health B.V., the Netherlands

• Data Processing: All personal and health‑related data are stored on secure EU‑based servers.

• Data Protection Officer: Abhinav Jain

• Data Minimization: We collect only what is strictly necessary for order fulfillment and delivery of our products and service.

• User Rights: You may access, correct, delete, or export your data at any time via your account portal or by emailing privacy@melonga.com.

Cookie & Tracking Policy

• We use only essential cookies to provide necessary products and services. Please refer to our privacy polices and Terms and Conditions for more details.

ISO 27001:2013 (planned for Q1 2025)

• Framework for information security management to protect confidentiality, integrity, and availability of data.

• Controls include network security, access management, vulnerability scanning, and incident response.

• CLIMACS Study: Ongoing, multi‑site clinical investigation evaluating Melonga’s efficacy and safety over a 12‑week program.

• Public Summaries: Topline results and patient‑reported outcomes are available on our Clinical Evidence page.

• Healthcare Professional Access: Full study protocol, statistical analysis, and peer‑reviewed publications provided upon request (clinical@melonga.com).

• Enforcement Discretion: For U.S. users, Melonga is offered solely as a “general wellness” app under the FDA’s Low‑Risk Wellness Policy.

• Marketing Claims: No claims to diagnose, treat, or cure any condition; all materials include the disclaimer:

  “This app has not been reviewed by the U.S. FDA and is intended for general wellness use only.”