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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 1 of 2

Device	Model / Reference	Registries	Class	Status
GlucoLeader Enhance Blood Glucose Test Strip(for PTA)	3L-10-120032	FDA UDI	Class II	Active
Easy@Home blood glucose monitoring system	3K-01-250037	FDA UDI	Class II	Active
Easy@Home EBG-100BLE blood glucose monitoring system	3K-01-25003G	FDA UDI	Class II	Active
FIA Biomed Precisa Blood Glucose Test Strip	3L-10-250036	FDA UDI	Class II	Active
GL GoodLife	IG01	FDA UDI	Class II	Unknown
FIA Salut vial packed test strip(for Elhenawy)	3S-01-140996	FDA UDI	Class II	Active
GlucoLeader Enhance Blood Glucose foil packed test strip	3L-10-14003T	FDA UDI	Class II	Active
GL GoodLife Blood Glucose Test Strip AC (50ct in foil)	AC11-Foil	FDA UDI	Class II	Unknown
GL GoodLife Blood Glucose Test Strip AC (50 Strips&lancets in foil)	3L-10-16003A	FDA UDI	Class II	Unknown
FIA Salut vial packed test strip(for SS)	3S-01-1400332	FDA UDI	Class II	Active
PRECICHEK AutoCode foil packed test strip	3L-10-16003H	FDA UDI	Class II	Active
LPOW Blood Glucose Test Strip	3S-01-25003E	FDA UDI	Class II	Active
FIA Biomed Precisa Blood Glucose Test Strip	3S-01-25003A	FDA UDI	Class II	Active
GL GoodLife Blood Glucose Monitoring System	AC-11 AC302	FDA UDI	Class II	Unknown
GL GoodLife AC11-Strip(foil)	3L-10-16003F	FDA UDI	Class II	Active
GL GoodLife Blood Glucose Test Strip-Foil For Cloudia	IG STRIP FOIL	FDA UDI	Class I	Unknown
Rosie SmartMeter Glucose Control Solutions	3C-01-160033	FDA UDI	Class I	Unknown
GlucoLeader Enhance Blood Glucose Test Strip	3S-01-22X034	FDA UDI	Class II	Active
GlucoLeader Enhance Blood Glucose Test Strip(BR/VM)	3S-01-14010B	FDA UDI	Class II	Active
GlucoLeader Enhance Blood Glucose Test Strip(for AF-SSA)	3S-01-1400333	FDA UDI	Class II	Active
FIA Salut foil packed test strip(for SS)	3L-10-14003A	FDA UDI	Class II	Active
GlucoLeader Enhance Blood Glucose Monitoring System	3K-01-140036	FDA UDI	Class II	Active
FIA Biomed Precisa Blood Glucose Test Strip	3L-10-250035	FDA UDI	Class II	Active
FIA Salut vial packed test strip	3S-01-1400A2	FDA UDI	Class II	Active
GL GoodLife Glucose Control Solution(Level 1)	GL GCS	FDA UDI	Class I	Unknown
PRECICHEK AutoCode foil packed test strip	3L-10-160031	FDA UDI	Class II	Active
GlucoLeader Enhance Blood Glucose Test Strip	GL vial	FDA UDI	Class II	Active
metene Enhance Blood Glucose Monitoring System	3K-01-250034	FDA UDI	Class II	Active
GL GoodLife AC-302 Blood Glucose Monitoring System	AC-11 AC302	FDA UDI	Class II	Unknown
GL GoodLife	AC11	FDA UDI	Class II	Active
GL GoodLife AC-302 Blood Glucose Monitoring System, Economy type(CORP.)	AC-11 AC302	FDA UDI	Class II	Active
FIA Salut CS06	3K-01-1400316	FDA UDI	Class II	Active
PRECICHEK AutoCode foil packed test strip	3L-10-16003D	FDA UDI	Class I	Active
Easy@Home Blood Glucose Test Strip	3S-01-250038	FDA UDI	Class II	Active
Precichek Ac300	3K-01-16003X	FDA UDI	Class I	Active
GlucoLeader Enhance Blood Glucose Test Strip(BR/BMT)	3S-01-14010J	FDA UDI	Class II	Active
GlucoLeader Enhance Blood Glucose Monitoring System(BR/BMT)	3K-01-14010C	FDA UDI	Class II	Active
GL GoodLife AC-302 Blood Glucose Monitoring System(CORP.)	AC-11 AC302	FDA UDI	Class II	Active
GoodLife foil packed test strip	3L-10-160032	FDA UDI	Class II	Active
FIA Salut vial packed test strip	3S-01-1400335	FDA UDI	Class II	Active
GlucoLeader Enhance Blood Glucose Test Strip(BR/IQ)	3S-01-14010A	FDA UDI	Class II	Active
PRECICHEK AutoCode foil packed test strip	3L-10-16003G	FDA UDI	Class I	Active
Rosie SmartMeter NFC Professional	AC-NFC Meter	FDA UDI	Class II	Unknown
PRECICHEK AutoCode vial packed test strip	3S-01-16003F	FDA UDI	Class I	Active
Rosie SmartMeter Test Strips 50ct(vial)	3S-01-16003A	FDA UDI	Class II	Unknown
GlucoLeader Enhance Blood Glucose Monitoring System(BR/IQ)	3K-01-140108	FDA UDI	Class II	Active
GlucoLeader Enhance Blood Glucose Monitoring System	3K-01-140039	FDA UDI	Class II	Active
Renpho Blood Glucose vial packed test strip	3S-01-1400A3	FDA UDI	Class II	Active
GlucoLeader Enhance Blood Glucose vial packed test strip	3S-01-1400336	FDA UDI	Class II	Active
PRECICHEK AutoCode AC300	3K-01-16003F	FDA UDI	Class II	Active

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