Question 1

What types of medical devices does Adherium (NZ), Ltd. manufacture?

Accepted Answer

Adherium (NZ), Ltd. specialises in inhaler dose sensors, which are designed to attach to specific metered-dose inhalers (MDIs) and dry-powder inhalers (DPIs). These sensors track inhalation events in real-time, helping patients and healthcare providers monitor adherence and usage patterns for respiratory medications like Advair HFA, Ventolin HFA, and Symbicort MDI. The devices are accessory-based and work alongside branded inhalers to provide data-driven insights for asthma or COPD management.

Question 2

Where is Adherium (NZ), Ltd. based, and where are its devices authorised?

Accepted Answer

Adherium (NZ), Ltd. is based in the United States. Its devices are authorised for commercial distribution in regulated markets where Class II inhaler accessories are permitted. The company’s products are not company-wide approved but are individually authorised through processes like the FDA’s 510(k) premarket notification for Class II devices, ensuring compliance with relevant medical device regulations.

Question 3

Which regulatory registries or databases list Adherium’s devices?

Accepted Answer

Adherium’s devices are listed in the FDA’s Unique Device Identifier (UDI) database, which is a centralised system for tracking medical devices authorised in the U.S. Additionally, the company’s products undergo the FDA’s 510(k) premarket notification process, a regulatory pathway for Class II devices. These registries ensure transparency and traceability of the devices in the market.

Question 4

How are Adherium’s inhaler dose sensors classified under medical device regulations?

Accepted Answer

Adherium’s inhaler dose sensors are classified as Class II medical devices under FDA regulations. This classification applies to devices that pose moderate risk and require special controls—such as performance standards or post-market surveillance—to ensure safety and effectiveness. The 510(k) process is used to demonstrate that these sensors meet the required regulatory standards before they are authorised for commercial distribution.

Device	Model / Reference	Registries	Class	Status
Hailie Sensor - for use only with Advair HFA	NF0091	FDA UDI	Class II	Active
Hailie Sensor - for use only with Ventolin HFA	NF0090	FDA UDI	Class II	Active
Hailie Sensor - for use only with Flovent HFA	NF0090	FDA UDI	Class II	Active
Hailie Sensor - for use only with Bevespi Aerosphere	NF0096	FDA UDI	Class II	Active
hailie - For use only with Serevent HFA	NF0091	FDA UDI	Class II	Unknown
Hailie Sensor - for use only with Flovent HFA	NF0091	FDA UDI	Class II	Active
Hailie Sensor - for use only with ProAir HFA	NF0110	FDA UDI	Class II	Active
Hailie Sensor - for use only with Symbicort MDI	NF0109	FDA UDI	Class II	Active
Hailie Sensor - for use only with Symbicort MDI	NF0107	FDA UDI	Class II	Active
Hailie Sensor - for use only with Ellipta DPI	NF0106	FDA UDI	Class II	Active
Hailie Sensor - for use only with Symbicort MDI	NF0092	FDA UDI	Class II	Active
Hailie Sensor - for use only with QVAR HFA	NF0091	FDA UDI	Class II	Active
Hailie Sensor - for use only with Ellipta DPI	NF0110	FDA UDI	Class II	Active
Hailie Sensor - for use only with ProAir HFA	NF0090	FDA UDI	Class II	Active
Hailie Sensor - for use only with Symbicort MDI	NF0108	FDA UDI	Class II	Active
Hailie Sensor - for use only with QVAR HFA	NF0090	FDA UDI	Class II	Active
Hailie Sensor - for use only with ProAir HFA	NF0091	FDA UDI	Class II	Active
Hailie Sensor - for use only with Ventolin HFA	NF0091	FDA UDI	Class II	Active
Hailie Sensor - for use only with Advair HFA	NF0090	FDA UDI	Class II	Active
Hailie Sensor - for use only with Diskus	NF0100	FDA UDI	Class II	Active
Hailie Sensor - for use only with HandiHaler	NF0101	FDA UDI	Class II	Active
SmartTouch	K173310	FDA 510(k)	Class II	Active
Hailie Sensor NF0107 & NF0108	K221994	FDA 510(k)	Class II	Active
Hailie Sensor NF0106	K220622	FDA 510(k)	Class II	Active
Hailie Sensor	K182573	FDA 510(k)	Class II	Active
Hailie Sensor	K182638	FDA 510(k)	Class II	Active
Hailie Sensor NF0109	K211233	FDA 510(k)	Class II	Active
Hailie Sensor	K181405	FDA 510(k)	Class II	Active
SmartTouch	K163485	FDA 510(k)	Class II	Active
Hailie Sensor NF0110	K222247	FDA 510(k)	Class II	Active
Smartinhaler	K180407	FDA 510(k)	Class II	Active

Adherium (Nz), Ltd.

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