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Guangzhou Wondfo Biotech Co., Ltd.

China · Guangzhou Guangdong · en.wondfo.com

✓ Record-verifiedregistrations found in 11 marketsEU SRN CN-MF-000000689

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, South Korea, Australia, Hong Kong, Israel, Russia — 11 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually. The China NMPA lookup is still pending.

Registrations by market

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

CNChinaNMPA

pendingnot queried

EUEuropean UnionEUDAMED

≥300UDI-DI device records

IVD A 12IVD general 288

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

44listed device types

Class I 8Class II 34Class III 0unclassified 2

plus 67 registration records and 43 510(k)

UKUnited KingdomMHRA PARD

180registered device records

IVD A 23IVD general 139Class C – Self-testing or Near-patient Testing 2IVD Annex II List A 1IVD Annex II List B 5IVD Devices for Self-Testing 10

BRBrazilANVISA

126registered devices

Class II 126

221 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

27 including historic records

TWTaiwanTFDA

7valid device licences

Class I 5Class II 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

IVD import 2

AUAustraliaTGA ARTG

7active ARTG entries

IVD Class 1 1IVD Class 2 5IVD Class 3 1

HKHong KongMDACS

4valid listings

IVD B 3IVD C 1

ILIsraelAMAR

19registrations

RURussiaRoszdravnadzor

39active registrations

Class 1 1Class 2a 32Class 2b 4Class 3 2

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 Union690 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States67 registration records, 43 510(k), 0 PMA, 3 excluded

United Kingdom180 confirmed, 0 excluded

Brazil126 confirmed, 0 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: GUANGZHOU WONDFO BIOTECH CO., LTD. · GUANG ZHOU WONDFO BIOTECH CO. LTDA · GUANGZHOU WONDFO BIOTECH CO. LTD · GUANGZHOU WONDFO BIOTECH CO., LTD

Regulatory identity

EU manufacturer SRN: CN-MF-000000689
EU authorised representative: CMC Medical Devices & Drugs SL
UK responsible person: Qarad UK Ltd.

FDA 510(k) clearances by year

22005

12009

12010

62011

62012

52013

62014

62015

12016

12017

22018

12020

22024

22025

12026

FDA listed device types

showing 8 of 44

Kit, Test, Pregnancy, Hcg, Over The Counter 1Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt 1Enzyme Immunoassay, Opiates 1Enzyme Immunoassay, Benzodiazepine 1Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings 1Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method 1Test, Benzodiazepine, Over The Counter 1Test, Tricyclic Antidepressants, Over The Counter 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06933289860130	SmarLumi	IVD general
EU	06933289860123	SmarLumi	IVD general
EU	06933289860116	SmarLumi	IVD general
EU	06933289860109	SmarLumi	IVD general
UK	59050	One Step EDDP Urine Test	IVD general
UK	55993	Activated Clotting Time (Non-anticoagulant) Reagent Kit (Clotting)	IVD general
UK	55994	Activated Clotting Time Reagent Kit (Clotting)	IVD general
US	K260065	SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx	2026-04-28
US	K252550	SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx	2025-11-18
US	K251289	WELLlife COVID-19 Antigen Test Rx	2025-10-22
BR	10163770011	MATURITY TEST TESTE DE MENOPAUSA	Class II
BR	10163770009	FERTILITY DAY TESTE DE OVULAÇÃO	Class II
BR	80638720089	HCG RAPID TEST	Class II