AED Certifications — DHA, MOHAP, FDA, CE, ISO 13485

Yes — the NeoPulse AED i5, i7 and i9 are registered with the Dubai Health Authority (DHA) as Class IIb medical devices. The DHA registration certificate is supplied as a PDF with every AED Machine sold across Dubai, and our supplier registration is renewed annually.

Yes — the NeoPulse AED range is registered with the UAE Ministry of Health and Prevention (MOHAP) for sale and use across all seven emirates. The MOHAP medical device registration number appears on every device label and on the compliance pack PDF.

CE marking certifies that an AED defibrillator complies with European Union Medical Device Regulation (MDR 2017/745) for safety, performance and quality. The CE certificate is issued by an EU Notified Body after a full technical file audit. NeoPulse AED machines carry CE Class IIb certification, the same standard required for use in EU hospitals.

FDA clearance (specifically 510(k) clearance for Class III AEDs) means the US Food & Drug Administration has reviewed the AED Machine and confirmed it is substantially equivalent in safety and effectiveness to other legally marketed AEDs. This is the strictest medical-device regulatory standard globally and signals the highest level of clinical validation.

ISO 13485 is the international quality management standard specifically for medical device manufacturers. An ISO 13485 certified facility (like ours) has audited processes for design, production, traceability, post-market surveillance and corrective action. For an AED, this means every device is built and tested under the same documented quality system as devices used in ICUs and operating theatres.

CE, FDA and ISO 13485 are recognised across all GCC countries as evidence of medical device quality. National-level registration is also held with SFDA (Saudi Arabia), MOPH (Qatar) and MOH (Oman). Every AED shipped across GCC includes the country-specific registration certificate.