Auto CPAP A01 now shipping in MENA — full compliance file available

The Auto CPAP A01 is now available through GHM across MENA destination countries. The device is a 4 to 20 cmH₂O auto-titrating positive airway pressure unit with integrated humidification and a 2.4-inch colour LCD interface, intended for adult obstructive sleep apnoea therapy in home-care settings.

Compliance file

The compliance file is the full one. CE marking under EU MDR 2017/745 with the manufacturer's Notified Body number visible on the Declaration of Conformity. ISO 13485 scope letter from the manufacturer's certified quality system. UDI carrier on every individual carton. Multilingual Instructions for Use, including English, French, and Arabic for our principal MENA destinations.

The file is available on request to buyers preparing tender responses and to clinic procurement teams evaluating the device against alternatives. Email compliance@ghmmedical.com with your tender reference or the procurement window you are working against, and the bundle returns within 24 business hours.

Clinical position

Auto CPAPs sit between fixed-pressure CPAPs and BiPAP devices in the obstructive sleep apnoea therapy ladder. They titrate breath-by-breath against measured airflow, which improves comfort for patients with positional or REM-dependent OSA — typically a meaningful share of the diagnosed adult population. The A01 is positioned for that clinical segment in clinic-prescribed home-care deployments.

It is not a replacement for clinic-grade titration during initial diagnosis. Sleep medicine specialists prescribing the A01 should continue to titrate in-lab where the protocol calls for it. The A01 is the device the patient takes home after the titration is established.

Logistics and pricing

First shipments cleared customs in Algiers last week, with onward delivery to the buyer's regional distribution centres completed inside the committed lead time. Two further consignments are en route to Cairo and Casablanca during February 2026.

List pricing is set per destination market and reflects the destination-specific regulatory and import overhead. Ministry of Health tender pricing is negotiated separately under the standard GHM tender response framework, with volume tier discounts at 50, 200, and 500-unit thresholds. Quotes are returned within 24 business hours of an RFQ submitted via the contact form or directly to info@ghmmedical.com.