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General Life Biotechnology Co., Ltd.

Taiwan · New Taipei City · www.glbiotech.com.tw

✓ Record-verifiedregistrations found in 4 markets

This company holds 4 NMPA certificates in China and has registrations in United States, United Kingdom, South Korea — 3 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

4China registrations

Class II 4

as of 2026-09-01

EUEuropean UnionEUDAMED

0UDI-DI device records

USUnited StatesFDA openFDA

2listed device types

Class I 2Class II 0Class III 0

plus 2 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

12registered device records

IVD Annex II List B 6IVD Devices for Self-Testing 6

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union1,784 raw hits, 300 excluded, 0 confirmed. Large result set — only the first 300 verified

United States2 registration records, 1 510(k), 0 PMA, 87 excluded

China4 certificates (Class III 0 / II 4 / I 0), as of 2026-09-01

United Kingdom12 confirmed, 17 excluded

Brazil0 confirmed, 6 excluded

Saudi Arabia0 confirmed, 4 excluded

Canada0 confirmed, 8 excluded

Manufacturer names merged into this page: GENERAL LIFE BIOTECHNOLOGY CO., LTD.

Regulatory identity

UK responsible person: MDSS-UK RP LIMITED
Exhibition record: CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Registration details (sample)

Market	Identifier	Name	Class / date
CN	国械注许20162400010	血糖试纸Blood Glucose Test Strip	Class II · 2025-06-12
CN	国械注许20172400001	总胆固醇试纸（干化学法）Total Cholesterol Test Strips	Class II · 2025-06-05
CN	国械注许20252220003	血糖、尿酸、总胆固醇监测系统	Class II · 2025-02-26
CN	国械注许20172400021	尿酸试纸（干化学法）Uric Acid Test Strip	Class II · 2021-12-29
UK	41819	BeneCheck II Glucose Control Solution	IVD Annex II List B
UK	53303	BeneCheck Glucose Test Strip	IVD Annex II List B
UK	62537	BeneCheck Uni Blood Glucose Meter	IVD Annex II List B
US	K123090	GLB BENECHECK PREMIUM GLU MONITORING SYSTEM	2013-11-22

General Life Biotechnology Co., Ltd.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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