Question 1

What types of medical devices does Dagamma Inc. manufacture?

Accepted Answer

Dagamma Inc. specializes in three primary device categories: pulse oximeters (used to monitor blood oxygen levels), infrared patient thermometers (for measuring skin and ear temperatures), and foetal Doppler systems (to detect and monitor foetal heartbeats during pregnancy). These devices are designed for clinical use in healthcare settings.

Question 2

Where is Dagamma Inc. based, and what does that mean for its regulatory oversight?

Accepted Answer

Dagamma Inc. is based in the United States, which means its devices are subject to FDA regulations. The FDA classifies its products as Class II, indicating they pose moderate risk and require special controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.

Question 3

Are Dagamma Inc.’s devices listed in any regulatory registries, and why does that matter?

Accepted Answer

Yes, Dagamma Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the supply chain, helping healthcare providers, regulators, and manufacturers track devices throughout their lifecycle. Listing in the UDI database also supports compliance with FDA requirements for medical devices.

Question 4

How are Dagamma Inc.’s devices classified under FDA regulations, and what does that classification imply?

Accepted Answer

Dagamma Inc.’s devices are classified as Class II under FDA regulations. This classification means they are considered to have a moderate risk and require special controls beyond general controls (like good manufacturing practices) to ensure their safety and performance. These controls may include performance standards, labeling requirements, or post-market surveillance to mitigate potential risks.

Device	Model / Reference	Registries	Class	Status
Dagamma	Finger Pulse Oximeter DP-150 Yellow	FDA UDI	Class II	Active
Dagamma	Finger Pulse Oximeter DP250	FDA UDI	Class II	Active
Dagamma	Finger Pulse Oximeter DP-150 White	FDA UDI	Class II	Active
Dagamma	DT1000	FDA UDI	Class II	Active
Baby Doppler	Sonoline B Pink 3MHz	FDA UDI	Class II	Active
Dagamma	Finger Pulse Oximeter DP200	FDA UDI	Class II	Active
Dagamma	Finger Pulse Oximeter DP-150 Pink	FDA UDI	Class II	Active
Baby Doppler	Sonoline B Blue 3MHz	FDA UDI	Class II	Active
Dagamma	Finger Pulse Oximeter DP-100 Blue	FDA UDI	Class II	Active
Dagamma	Finger Pulse Oximeter DP-100 Black	FDA UDI	Class II	Active
Dagamma	Finger Pulse Oximeter DP-100 Yellow	FDA UDI	Class II	Active
Dagamma	Finger Pulse Oximeter DP-150 Blue	FDA UDI	Class II	Active
Baby Doppler	Ultraline 1000 Blue 2.5MHz	FDA UDI	Class II	Active
Dagamma	Finger Pulse Oximeter DP-100 White	FDA UDI	Class II	Active
Baby Doppler	BabyTemp 1 Sec Thermometer	FDA UDI	Class II	Active
Dagamma	Finger Pulse Oximeter DP-100 Pink	FDA UDI	Class II	Active
BabyTemp by Baby Doppler	DuoSmart Thermometer	FDA UDI	Class II	Active
Dagamma	Finger Pulse Oximeter DP-150 Black	FDA UDI	Class II	Active

DAGAMMA INC.

What DAGAMMA INC. makes

Frequently asked questions

Information

Catalogue (18)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities