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HMD BIOMEDICAL INC.

Taiwan·TW-MF-000032809

Last updated May 27, 2026

Information

Country: Taiwan
Address: No.181, Minsheng Street, Xinpu Township, Hsinchu County, Taiwan
Website: www.hmdbio.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +88635895000#6200
PRRC Contact: Andy Peng
EUDAMED SRN: TW-MF-000032809
FDA FEI Number: —
DUNS Number: 658644174

Catalogue (27)

Device	Model / Reference	Registries	Class	Status
GlucoLeader Enhance Blood Glucose Test Strip	3L-10-350034	EUDAMED	IVD Annex II List B	Active
FIA Blood Glucose Monitoring System (G2)	K131173	FDA 510(k)	Class II	Active
Precichek Ns-101 Poct Professional Blood Glucose Monitoring System	K113314	FDA 510(k)	Class II	Active
Goodlife Cs-200 (single Patient Use), Cs-200 Professional (multiple Patient Use) Blood Glucose Monitoring Systems	K121433	FDA 510(k)	Class II	Active
GlucoLeader Enhance 2 Blood Glucose Monitoring System	K212248	FDA 510(k)	Class II	Active
Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose Monitoring System, Goodlife AC-302 Blood Glucose Monitoring System, Goodlife AC 303 Blood Glucose Monitoring System, Goodlife AC-304 Blood Glucose Monitoring System Goodlife AC-305 Blood Glucose Monitoring System, Goodlife AC-300 Professional Blood Glucose Monitoring System, Goodlife AC-301 Professional Blood Glucose Monitoring System Goodlife AC-30	K140150	FDA 510(k)	Class II	Active
Glucoleader Value	K023279	FDA 510(k)	Class II	Active
Glucoleader Enhance Self-Monitoring Of Blood Glucose System	K032985	FDA 510(k)	Class II	Active
Gl Goodlife Series Blood Glucose Monitoring Sysmtem	K113307	FDA 510(k)	Class II	Active
Test, Blood Glucose System	K120064	FDA 510(k)	Class II	Active
GlucoLeader Enhance Blood Glucose Test Strip	3S-01-250062	EUDAMED	IVD Annex II List B	Active
GlucoLeader Enhance Blood Glucose Test Strip	3S-01-16003G	EUDAMED	IVD Annex II List B	Active
GL GoodLife 001 Blood Glucose Monitoring System	3K-01-250031	EUDAMED	IVD Annex II List B	Active
GlucoLeader Enhance Blood Glucose Monitoring System	3K-01-250035	EUDAMED	IVD Annex II List B	Active
GlucoLeader Enhance Glucose Control Solution	3C-01-250062	EUDAMED	IVD Annex II List B	Active
FIABiomed Precisa Blood Glucose Monitoring System	3K-01-350031 / 3K-01-350151	EUDAMED	IVD Annex II List B	Active
GL GoodLife 001 Blood Glucose Test Strip	3S-01-250039	EUDAMED	IVD Annex II List B	Active
GlucoLeader Enhance 2 Blood Glucose Test Strip	3S-01-250081	EUDAMED	IVD Annex II List B	Active
FIABiomed Precisa Blood Glucose Test Strip	3S-01-350035	EUDAMED	IVD Annex II List B	Active
FIABiomed Precisa Blood Glucose Test Strip	3L-10-350031	EUDAMED	IVD Annex II List B	Active
GlucoLeader Enhance Blood Glucose Test Strip	3L-10-250062	EUDAMED	IVD Annex II List B	Active
FIABiomed Precisa Blood Glucose Test Strip	3S-01-350051	EUDAMED	IVD Annex II List B	Active
FIABiomed Precisa Blood Glucose Monitoring System	3K-01-350034	EUDAMED	IVD Annex II List B	Active
GlucoLeader Enhance Blood Glucose Test Strip	3S-01-250037	EUDAMED	IVD Annex II List B	Active
GL GoodLife 001 Blood Glucose Test Strip	3L-10-250031	EUDAMED	IVD Annex II List B	Active
GlucoLeader Enhance Blood Glucose Monitoring System	3K-01-250062	EUDAMED	IVD Annex II List B	Active
GlucoLeader Enhance Blood Glucose Monitoring System	3K-01-160037	EUDAMED	IVD Annex II List B	Active

Related Companies

Authorised Representatives

Luana Med. B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Hmd Biomedical, LLC US