UK MDR Certification and Market Expansion Plans
In 2023, NGPOD Global achieved a significant regulatory milestone by obtaining certification under the UK Medical Devices Regulations 2002 (as amended). This certification enables us to apply the UKCA mark to our products, facilitating sales across England, Scotland, and Wales. This achievement reflects our commitment to meeting the highest regulatory standards within the UK market.
Alongside our UKCA certification, we continue to maintain our certification under the Medical Device Directive 93/42/EEC, allowing us to apply the CE mark to our products for distribution within Europe. This dual certification underscores our dedication to regulatory excellence in both the UK and European markets.
Looking ahead, we are currently well along the way with the transition process for the Medical Device Regulation (MDR 2017/745), which is anticipated to be fully approved in 2025. This will ensure that NGPOD Global remains compliant with evolving regulations in Europe.
Additionally, we are preparing for expansion into the US market by submitting our 510(k) application to the FDA, seeking approval for our products in the United States.
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NGPOD to Showcase Next-Generation Digital pH Testing at HETT 2025WHAT IS NGPOD?
NGPod: Stop "Never Events", improve patient recovery and reduce costs
The NGPod handheld devices overcomes many of the risks associated with existing Nasogastric placement confirmation methods.
- No aspiration required
- No interpretation required. Get a clear "Yes/No" answer
- Rapid result [c.15 seconds]
- Reduce delays to patients treatment, hydration and nutrition
- More cost-effective than testing with pH strips
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