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Hmd Biomedical, LLC

Last updated May 24, 2026

What Hmd Biomedical, LLC makes

Hmd Biomedical, LLC manufactures glucose in vitro diagnostic devices, including test strips and monitoring systems for point-of-care and home-use settings, as well as control materials for isocitrate dehydrogenase 2 (IDH2) gene mutation testing.

The company's devices are classified as Class I and Class II medical devices and are listed in the FDA's 510(k) and UDI registries; the manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What does Hmd Biomedical, LLC make?

Where is Hmd Biomedical, LLC based?

Hmd Biomedical, LLC is based in the United States, as indicated by the country field in the device data.

Which regulatory registries list devices from Hmd Biomedical, LLC?

Devices from Hmd Biomedical, LLC are listed in the FDA's 510(k) and UDI registries, as specified in the LISTED IN field of the device data.

How are the devices made by Hmd Biomedical, LLC classified?

The devices manufactured by Hmd Biomedical, LLC are classified as Class I and Class II medical devices, according to the DEVICE CLASSES field in the provided data.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: —
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: —

Catalogue (76)

Page 2 of 2

Device	Model / Reference	Registries	Class	Status
GlucoLeader Enhance Blood Glucose vial packed test strip	3S-01-140035	FDA UDI	Class II	Active
PRECICHEK AutoCode foil packed test strip	3L-10-16003B	FDA UDI	Class I	Active
GL GoodLife Glucose Control Solutions	3C-01-160032	FDA UDI	Class I	Unknown
FIA Salut vial packed test strip	3S-01-1400334	FDA UDI	Class II	Active
GL GoodLife Blood Glucose Meter AC-11	3K-01-16003S	FDA UDI	Class II	Unknown
LPOW blood glucose monitoring system(Meter)	3K-01-25003E	FDA UDI	Class II	Active
GL GoodLife	AC11-NFC	FDA UDI	Class II	Unknown
FIA Biomed Precisa blood glucose monitoring system	3K-01-250039	FDA UDI	Class II	Active
FIA Salut foil packed test strip	3L-10-140033	FDA UDI	Class II	Active
GlucoseLeader Enhance Blood Glucose Monitoring System(BR/VM)	3K-01-14010B	FDA UDI	Class II	Active
FIA Biomed Precisa blood glucose monitoring system	3K-01-25003F	FDA UDI	Class II	Active
Rosie SmartMeter	AC11-NFC	FDA UDI	Class II	Unknown
GL GoodLife AC300 Test Strip-Vial	AC-11 vial	FDA UDI	Class II	Unknown
PRECICHEK AutoCode vial packed test strip	3S-01-160037	FDA UDI	Class I	Active
GL GoodLife Blood Glucose Test Strip	AC-11 AC302 (vial)	FDA UDI	Class II	Unknown
Rosie SmartMeter	AC11	FDA UDI	Class II	Unknown
Rosie SmartMeter Professional Strip	AC-11 Pro-Strip	FDA UDI	Class II	Unknown
Easy@Home EBG-100BLE Blood Glucose Test Strip	3S-01-25003F	FDA UDI	Class II	Active
metene Enhance Blood Glucose vial packed test strip	3S-01-250035	FDA UDI	Class II	Active
GlucoLeader Enhance Blood Glucose vial packed test strip	3S-01-14003Y	FDA UDI	Class II	Active
PRECICHEK AutoCode AC302	3K-01-16003A	FDA UDI	Class I	Active
GL GoodLife Blood Glucose Test Strip(CORP.)	AC-11 AC302 (vial)	FDA UDI	Class II	Active
FIA Salut vial packed test strip(for SS)	3S-01-1400A1	FDA UDI	Class II	Active
Renpho Blood Glucose Monitoring System	3K-01-1400A2	FDA UDI	Class II	Active
PRECICHEK AutoCode vial packed test Strip	3S-01-160032	FDA UDI	Class II	Active
Evolution Blood Glucose Monitoring System	K072369	FDA 510(k)	Class II	Active

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