MD Atlas update: Jun 28, 2026

HMD Biomedical Inc.

TW-MF-000032809

Active22 devices

Address: Minsheng Street, No.181 30548 Xinpu Township, Hsinchu County
Role: Manufacturer
Date of registration: Jan 19, 2023
Country: Taiwan

HMD Biomedical Inc. is a medical device manufacturer registered in EUDAMED. The company has 22 devices on the EU market across 2 countries. Headquartered in Xinpu Township, Hsinchu County, Taiwan. Explore the regulatory profile, devices and certificates on MD Atlas.

About HMD Biomedical Inc.

: TW-MF-000032809
Role: Manufacturer
Country: Taiwan
Organization name: HMD Biomedical Inc.
EU VAT number: Not applicable
Date of registration: Jan 19, 2023

Contact details for HMD Biomedical Inc.

Phone: +88635895000#6200
Email: license@hmdbio.com
Website: http://www.hmdbio.com
Address: NO.181, MINSHENG STREET 30548 XINPU TOWNSHIP, HSINCHU COUNTY TAIWAN

Competent authority

Name: Ministerie van Volksgezondheid, Welzijn en Sport

Phone: +31 70 340 79 11
Email: medische_hulpmiddelen@minvws.nl

Officers and regulatory representatives of HMD Biomedical Inc.

PENG Andy
1.Maintain the effective operation of the quality management system. 2.Ensure that the performance, efficacy and safety of medical products and their planning, verification, and validation are in compliance with regulations. 3.Ensure that the listed products have completed the relevant registration and certification procedures. 4.Ensure that all relevant inspection and release procedures are completed according to the quality system. 5.Maintain the product post-market surveillance system.
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Importers

1 EU importer places this manufacturer's devices

Data export

Export the 22 devices of HMD Biomedical Inc.

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Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
FIABiomed Precisa Blood Glucose Monitoring System	FIABiomed Precisa Blood Glucose Monitoring System	`3K-01-350034`	`04260236851104`	1	On the market
FIABiomed Precisa Blood Glucose Monitoring System	FIABiomed Precisa Blood Glucose Monitoring System	`3K-01-350031 / 3K-01-350151`	`04260236850800`	1	On the market
FIABiomed Precisa Blood Glucose Test Strip	FIABiomed Precisa Blood Glucose Test Strip	`3S-01-350035`	`04260236850978`	1	On the market
FIABiomed Precisa Blood Glucose Test Strip	FIABiomed Precisa Blood Glucose Test Strip	`3S-01-350031`	`04260236850817`	1	On the market
FIABiomed Precisa Blood Glucose Test Strip	FIABiomed Precisa Blood Glucose Test Strip	`3L-10-350031`	`04260236850824`	1	On the market
FIABiomed Precisa Blood Glucose Test Strip	FIABiomed Precisa Blood Glucose Test Strip	`3S-01-350033`	`04260236850961`	1	On the market
GL GoodLife 001 Blood Glucose Monitoring System	GL GoodLife 001 Blood Glucose Monitoring System	`3K-01-250031`	`04711200722376`	1	On the market
GL GoodLife 001 Blood Glucose Monitoring System	GL GoodLife 001 Blood Glucose Monitoring System	`3K-01-250032`	`04711200722758`	1	On the market
GL GoodLife 001 Blood Glucose Test Strip	GL GoodLife 001 Blood Glucose Test Strip	`3L-10-250031`	`04711200722413`	1	On the market
GL GoodLife 001 Blood Glucose Test Strip	GL GoodLife 001 Blood Glucose Test Strip	`3S-01-250032`	`04711200722499`	1	On the market
GL GoodLife 001 Blood Glucose Test Strip	GL GoodLife 001 Blood Glucose Test Strip	`3S-01-250039`	`04711200723137`	1	On the market
GL GoodLife 001 Blood Glucose Test Strip	GL GoodLife 001 Blood Glucose Test Strip	`3L-10-250032`	`04711200722468`	1	On the market
GL GoodLife 001 Blood Glucose Test Strip	GL GoodLife 001 Blood Glucose Test Strip	`3S-01-250031`	`04711200722383`	1	On the market
GlucoLeader Enhance Blood Glucose Monitoring System	GlucoLeader Enhance Blood Glucose Monitoring System	`3K-01-250035`	`04711200723120`	1	On the market
GlucoLeader Enhance Blood Glucose Monitoring System	GlucoLeader Enhance Blood Glucose Monitoring System	`3K-01-250063`	`04711200724257`	1	On the market
GlucoLeader Enhance Blood Glucose Monitoring System	GlucoLeader Enhance Blood Glucose Monitoring System	`3K-01-250062`	`04711200723946`	1	On the market
GlucoLeader Enhance Blood Glucose Monitoring System	GlucoLeader Enhance Blood Glucose Monitoring System	`3K-01-160037`	`04711200721621`	1	On the market
GlucoLeader Enhance Blood Glucose Test Strip	GlucoLeader Enhance Blood Glucose Test Strip	`3S-01-16003G`	`04711200722475`	1	On the market
GlucoLeader Enhance Blood Glucose Test Strip	GlucoLeader Enhance Blood Glucose Test Strip	`3S-01-250037`	`04711200723328`	1	On the market
GlucoLeader Enhance Blood Glucose Test Strip	GlucoLeader Enhance Blood Glucose Test Strip	`3S-01-160034`	`04711200721645`	1	On the market
GlucoLeader Enhance Blood Glucose Test Strip	GlucoLeader Enhance Blood Glucose Test Strip	`3L-10-350034`	`04711200722772`	1	On the market
GlucoLeader Enhance Glucose Control Solution	GlucoLeader Enhance Glucose Control Solution	`3C-01-250062`	`04711200723335`	1	On the market

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
FIABiomed Precisa Blood Glucose Monitoring System	FIABiomed Precisa Blood Glucose Monitoring System	`3K-01-350034`	`04260236851104`	1	On the market
FIABiomed Precisa Blood Glucose Monitoring System	FIABiomed Precisa Blood Glucose Monitoring System	`3K-01-350031 / 3K-01-350151`	`04260236850800`	1	On the market
FIABiomed Precisa Blood Glucose Test Strip	FIABiomed Precisa Blood Glucose Test Strip	`3S-01-350035`	`04260236850978`	1	On the market
FIABiomed Precisa Blood Glucose Test Strip	FIABiomed Precisa Blood Glucose Test Strip	`3S-01-350031`	`04260236850817`	1	On the market
FIABiomed Precisa Blood Glucose Test Strip	FIABiomed Precisa Blood Glucose Test Strip	`3L-10-350031`	`04260236850824`	1	On the market
FIABiomed Precisa Blood Glucose Test Strip	FIABiomed Precisa Blood Glucose Test Strip	`3S-01-350033`	`04260236850961`	1	On the market
GL GoodLife 001 Blood Glucose Monitoring System	GL GoodLife 001 Blood Glucose Monitoring System	`3K-01-250031`	`04711200722376`	1	On the market
GL GoodLife 001 Blood Glucose Monitoring System	GL GoodLife 001 Blood Glucose Monitoring System	`3K-01-250032`	`04711200722758`	1	On the market
GL GoodLife 001 Blood Glucose Test Strip	GL GoodLife 001 Blood Glucose Test Strip	`3L-10-250031`	`04711200722413`	1	On the market
GL GoodLife 001 Blood Glucose Test Strip	GL GoodLife 001 Blood Glucose Test Strip	`3S-01-250032`	`04711200722499`	1	On the market
GL GoodLife 001 Blood Glucose Test Strip	GL GoodLife 001 Blood Glucose Test Strip	`3S-01-250039`	`04711200723137`	1	On the market
GL GoodLife 001 Blood Glucose Test Strip	GL GoodLife 001 Blood Glucose Test Strip	`3L-10-250032`	`04711200722468`	1	On the market
GL GoodLife 001 Blood Glucose Test Strip	GL GoodLife 001 Blood Glucose Test Strip	`3S-01-250031`	`04711200722383`	1	On the market
GlucoLeader Enhance Blood Glucose Monitoring System	GlucoLeader Enhance Blood Glucose Monitoring System	`3K-01-250035`	`04711200723120`	1	On the market
GlucoLeader Enhance Blood Glucose Monitoring System	GlucoLeader Enhance Blood Glucose Monitoring System	`3K-01-250063`	`04711200724257`	1	On the market
GlucoLeader Enhance Blood Glucose Monitoring System	GlucoLeader Enhance Blood Glucose Monitoring System	`3K-01-250062`	`04711200723946`	1	On the market
GlucoLeader Enhance Blood Glucose Monitoring System	GlucoLeader Enhance Blood Glucose Monitoring System	`3K-01-160037`	`04711200721621`	1	On the market
GlucoLeader Enhance Blood Glucose Test Strip	GlucoLeader Enhance Blood Glucose Test Strip	`3S-01-16003G`	`04711200722475`	1	On the market
GlucoLeader Enhance Blood Glucose Test Strip	GlucoLeader Enhance Blood Glucose Test Strip	`3S-01-250037`	`04711200723328`	1	On the market
GlucoLeader Enhance Blood Glucose Test Strip	GlucoLeader Enhance Blood Glucose Test Strip	`3S-01-160034`	`04711200721645`	1	On the market
GlucoLeader Enhance Blood Glucose Test Strip	GlucoLeader Enhance Blood Glucose Test Strip	`3L-10-350034`	`04711200722772`	1	On the market
GlucoLeader Enhance Glucose Control Solution	GlucoLeader Enhance Glucose Control Solution	`3C-01-250062`	`04711200723335`	1	On the market

HMD Biomedical Inc.

About HMD Biomedical Inc.

Contact details for HMD Biomedical Inc.

Competent authority

Officers and regulatory representatives of HMD Biomedical Inc.

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Importers

Export the 22 devices of HMD Biomedical Inc.

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About HMD Biomedical Inc.

Contact details for HMD Biomedical Inc.

Competent authority

Officers and regulatory representatives of HMD Biomedical Inc.

Statistics for HMD Biomedical Inc.

Certificate health for HMD Biomedical Inc.

Related documents

Devices by risk class

Device catalog for HMD Biomedical Inc.

Device families (Basic UDI-DI) of HMD Biomedical Inc.

Market presence of HMD Biomedical Inc.

Connected operators

Importers

Export the 22 devices of HMD Biomedical Inc.

Related searches

Certificate health for HMD Biomedical Inc.

Statistics for HMD Biomedical Inc.

Market presence of HMD Biomedical Inc.

Devices by risk class

Related documents

Device families (Basic UDI-DI) of HMD Biomedical Inc.

Device catalog for HMD Biomedical Inc.