SFDA Ready
BT5.3 Neckband Biometric Health Monitor Earphones
- Dual-Mode SpO2 & Heart Rate
- HD LED Power & Bio-Display
- Heat Resistant Silicon (55°C)
Engineered for high thermal tolerance, photoplethysmography (PPG) accuracy across diverse skin tones, and seamless synchronization with hospital information systems (HIS) via dual-platform Bluetooth Low Energy (BLE 5.4).
Aligning with Saudi Vision 2030's Health Sector Transformation Program (HSTP), our health monitoring solutions bridge the gap between enterprise clinical remote patient monitoring (RPM) and lifestyle wellness wearables across KSA.
During the Hajj and Umrah seasons in Makkah and Madinah, extreme crowd density combined with ambient temperatures exceeding 45°C presents severe heat stroke risks. Our wearable monitors integrate real-time skin temperature sensors, hydration estimation algorithms, and automated heart-rate spike alerts transmitted directly via BLE to pilgrim management applications.
Saudi Ministry of Health directives prioritize remote chronic disease management—specifically targeting Type 2 diabetes and hypertension, which affect over 25% of the regional adult population. Our smart health devices offer seamless open-API software development kits (SDKs) to link patient pulse blood oxygen (SpO2), HRV, and ECG metrics directly into Seha / Nphies EHR networks.
Fast timing changes during the Holy Month of Ramadan significantly disrupt sleep architecture and metabolic equilibrium. Specialized firmware updates within our companion applications automatically shift baseline circadian tracking models, providing Saudi users with localized sleep staging, nocturnal oxygenation dips, and hydration recovery feedback post-Iftar.
Exporting health wearables to Saudi Arabia requires engineering modifications that standard commercial devices lack. High ambient UV radiation, airborne desert particulates (PM10 sand dust), and extreme thermal stress degrade standard lithium batteries and optical sensors within months.
Our OEM factory production lines incorporate strict industrial grade safeguards specifically validated for Middle Eastern climate stress:
The Saudi Arabian medical device and personal health monitoring market is undergoing unprecedented expansion. Fueled by government investments in smart cities like NEOM, Qiddiya, and Red Sea Global, connected health hardware demand is shifting from basic step counters to clinical-grade biometric telemetry.
The Saudi Food and Drug Authority (SFDA) has established strict pathways for non-invasive health wearables that broadcast heart rate, blood oxygen (SpO2), or ECG metrics. Factory partners must provide complete technical dossiers including ISO 13485 audits, IEC 60601 electrical safety testing, and CB Scheme certifications.
All imported electronic products entering Jeddah Islamic Port, King Abdulaziz Port Dammam, or Riyadh Dry Port must be registered via the SABER online platform. Our compliance team handles SASO (Saudi Standards, Metrology and Quality Organization) Certificate of Conformity (PCoC and SCoC) issuance directly.
Corporate buyers in KSA—including government entities, insurance providers, and pharmaceutical firms—require fully localized mobile applications. Our software architecture supports Right-to-Left (RTL) Arabic typography, voice alerts in regional dialects, and data hosted on locally compliant cloud infrastructure (Saudi Cloud First Policy).
As a premier health monitor manufacturer and exporter, our production facilities utilize automated SMT lines, ISO Class 8 cleanrooms, and stringent 100% visual and electronic testing protocols before shipment.
We provide Saudi wholesale importers, enterprise brand owners, and hospital procurement channels with full OEM/ODM manufacturing transparency:
Detailed technical and commercial answers regarding SFDA registration, factory MOQs, custom branding, and regional delivery logistics.
We provide full technical documentation dossiers required by the Saudi Food and Drug Authority (SFDA) for Medical Device Marketing Authorization (MDMA) or GHTF notification. This includes ISO 13485 Quality Management System certificates, CE Declaration of Conformity, IEC 62368-1 / IEC 60601 test reports, biocompatibility reports for skin-contact silicone/metal materials, and clinical trial validation data for PPG optical sensors.
All our health monitors utilize high-density Lithium Polymer batteries integrated with Seiko-designed NTC thermal protection circuits. Battery cells undergo rigorous thermal exposure tests (storage at 65°C for 72 hours, thermal cycling from -20°C to +60°C) and carry UN38.3, MSDS, and IEC 62133 safety clearances to ensure complete safety during Saudi summer transit and usage.
Yes. Our in-house app development team provides complete white-label OEM solutions. We implement full Right-to-Left (RTL) Arabic localization, custom app icons, localized push notifications, and server integrations compliant with Saudi National Cybersecurity Authority (NCA) data residency guidelines.
For standard factory-neutral inventory with custom laser-engraved branding or localized packaging, our MOQ starts at 500 units per SKU. For full ODM customized tooling, specialized casing colors, or proprietary sensor configurations, MOQ typically ranges between 1,000 and 3,000 units depending on technical complexity.
We work directly with SASO-accredited conformity assessment bodies (such as Intertek, SGS, or TÜV Rheinland) to issue the Product Certificate of Conformity (PCoC) and Shipment Certificate of Conformity (SCoC) via the SABER platform prior to vessel departure, ensuring seamless customs clearance at Jeddah, Dammam, or King Khalid International Airport, Riyadh.
We support standard B2B international payment structures including Irrevocable Letter of Credit (L/C at sight), Telegraphic Transfer (T/T with 30% deposit and 70% balance post-inspection), and DP terms for established corporate partners. All products carry a 2-year warranty with spare unit buffer allowances included directly in container shipments.
Request customized OEM/ODM quotes, technical SFDA compliance dossiers, or factory sample kits dedicated to the Saudi Arabian market.
Dispatched from our UK warehouse with tracked shipping.
Every smartwatch and audio product is covered as standard.
One companion app across the whole product ecosystem.
Pairing, firmware and accessory help from our support team.