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Guangzhou Wondfo Biotech Co., Ltd.

China·CN-MF-000000689

Last updated September 17, 2026

What Guangzhou Wondfo Biotech Co., Ltd. makes

Guangzhou Wondfo Biotech manufactures in vitro diagnostic and imaging products, including a microscope slide stainer IVD, the Finecare test platform, SmarLumi devices, the U‑Card™ 200, an automated digital slide scanning and analysis system, and PA‑Bluing reagent.

These devices fall under Class A, Class I, Class II, IVD Annex II List B, IVD General, IVD self‑testing, and U categories, and are listed in the EU’s Eudamed database and the U.S. FDA 510(k) system. The company is based in China.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Guangzhou Wondfo Biotech manufacture?

Guangzhou Wondfo Biotech produces in‑vitro diagnostic (IVD) and imaging products. The most common category listed is a microscope slide stainer IVD, and its portfolio also includes the Finecare test platform, SmarLumi devices, the U‑Card™ 200, an automated digital slide scanning and analysis system, and PA‑Bluing reagent. This answer is based directly on the device list provided.

Where is Guangzhou Wondfo Biotech located?

The company’s address is indicated by the country code CN, which means it is based in China. This location information comes from the COUNTRY field in the supplied data.

In which regulatory registries are Guangzhou Wondfo Biotech’s devices listed?

The devices are recorded in the European Union’s Eudamed database and the United States FDA 510(k) system. The LISTED IN field explicitly names eudamed and fda_510k, so those are the registries where the company’s products appear.

How are Guangzhou Wondfo Biotech’s devices classified under regulatory categories?

According to the DEVICE CLASSES entry, the company’s products fall into several categories: Class A, Class I, Class II, IVD Annex II List B, IVD General, IVD devices for self‑testing, and a category labeled ‘U’. This reflects the range of risk and regulatory pathways applicable to its IVD and imaging devices.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: China
Address: No.8, Lizhishan Road, Guangzhou, China
Website: en.wondfo.com.cn
This website did not respond in time when we last checked. Last checked 2026-09-18.
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Yongfang Lv
EUDAMED SRN: CN-MF-000000689
FDA FEI Number: 3004635103
DUNS Number: —

Catalogue (188)

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Device	Model / Reference	Registries	Class	Status
Finecare	W893P0001	EUDAMED	IVD General	Active
PA-Retrieval Solution(pH6.0)	WF19P0001	EUDAMED	Class A	Active
Finecare	W813	EUDAMED	IVD General	Active
Finecare	W216	EUDAMED	IVD General	Active
PA-Immunochromogenic Reagent (Dual staining)	WDB1P0002	EUDAMED	Class A	Active
Finecare	W205	EUDAMED	IVD General	Active
Finecare	W259	EUDAMED	IVD General	Active
Finecare	W222	EUDAMED	IVD General	Active
PA-Retrieval Solution(pH9.0)	WF18P0001	EUDAMED	Class A	Active
Finecare	W210P0004	EUDAMED	IVD General	Active
Finecare	W201	EUDAMED	IVD General	Active
Automatic Blood Gas Analyzer Solution Pack	W795P0001	EUDAMED	IVD General	Active
Finecare	WS06P0001	EUDAMED	IVD General	Active
Finecare	W898P0001	EUDAMED	IVD General	Active
Finecare	W867-Z0P1-AG	EUDAMED	IVD General	Active
Finecare	W239	EUDAMED	IVD General	Active
Finecare	W245	EUDAMED	IVD General	Active
Activated Clotting Time (Non-anticoagulant) Reagent Kit (Clotting)	W483P0007	EUDAMED	IVD General	Active
Finecare™ PSA Control	W814-L, W814-M, W814-H	EUDAMED	IVD Annex II List B	Active
One Step Prostate Specific Antigen (PSA) Whole Blood/Serum/Plasma Test	W31-C4P	EUDAMED	IVD Annex II List B	Active
One Step FSH Urine Test	W52-C	EUDAMED	IVD devices for self-testing	Active
Finecare™ PSA Rapid Quantitative Test	W209	EUDAMED	IVD Annex II List B	Active
SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx	K260065	FDA 510(k)	Class II	Active
Wondfo Methadone Urine Test (mtd 200), Wondofo Morphine Urine Test (mop 100)	K131232	FDA 510(k)	Class II	Active
Cr3 Keyless Split Sample Cup Phencyclidien - Methylenedioxymethamphetamine	K142044	FDA 510(k)	U	Active
SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Test Cassette; SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel	K241741	FDA 510(k)	Class II	Active
Preview Digital Pregnancy Test	K173229	FDA 510(k)	Class II	Active
Wondfo T-Cup Multi-Drug Urine Test Cup	K182701	FDA 510(k)	Class II	Active
Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx	K202567	FDA 510(k)	Class II	Active
Wondfo Amphetamine Urine Test (amp 300), Wondfo Methamphetamine Urine Test (met 500)	K122961	FDA 510(k)	Class II	Active
Wondfo Multi-Drug Urine Test Cup, Panel	K133968	FDA 510(k)	Class II	Active
Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream	K150022	FDA 510(k)	Class II	Active
Wondfo Cannabinoids Urine Test Wondfo Propoxyphene Urine Test	K121557	FDA 510(k)	Class II	Active
One Step Hcg Urine/Serum Test	K072500	FDA 510(k)	Class II	Active
Wondfo CR3 Keyless Split Sample Cup	K151478	FDA 510(k)	Class II	Active
Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard)	K161214	FDA 510(k)	Class II	Active
Cr3 Keyless Split Sample Cup(opi-Bzo)	K140089	FDA 510(k)	Class II	Active
Wondfo Methylenedioxymethamphetamine Urine Test, Wondfo Morphine Urine Test	K112236	FDA 510(k)	Class II	Active
Acon Bup One Step Buprenorphine Test Strip	K130055	FDA 510(k)	Class II	Active
Wondfo Buprenorphine Urine Test Wondfo Oxycodone Urine Test	K113624	FDA 510(k)	Class II	Active
Wondfo Methadone Urine Test, Opiate Test	K112310	FDA 510(k)	Class II	Active
CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids	K150179	FDA 510(k)	Class II	Active
Wondfo Oxazepam Urine Test (bzo 200) And Wondfo Methamphetamine Urine Test (met 300)	K132630	FDA 510(k)	Class II	Active
Wondfo Cocaine Urine Test (coc 100), Wondfo Cannabinoids Urine Test (thc 40)	K131754	FDA 510(k)	Class II	Active
Wondfo Amphetamine Urine Test Wondfo Barbiturates Urine Test Wondfo Benzodiazepines Urine Test	K121987	FDA 510(k)	Class II	Active
CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine	K142609	FDA 510(k)	Class II	Active
Wondfo Multi-Drug Urine Test Cup Model W2002-Cu; W2003-Cu; W2004-Cu; W2005-Cu; W2006-Cu; W2007-Cu; W2008-Cu; W2009-Cu;	K122904	FDA 510(k)	Class II	Active
SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx	K252550	FDA 510(k)	Class II	Active
Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)	K241317	FDA 510(k)	Class II	Active
Wondfo Multi-Drug Urine Test Cup Wondfo Multi-Drug Urine Test Panel	K121166	FDA 510(k)	Class II	Active

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FDA Recalls (3)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

There are 3 recall records for Guangzhou Wondfo Biotech Co., Ltd., all initiated on May 18, 2018. The statuses of these recalls are recorded as open and classified. The reason given for the recalls is the potential for failure of the saliva collection device in the TCube One Step Multi-Drug Oral Fluid Test Cube, where the foam tip could become dislodged in the user's mouth, creating a choking hazard.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
May 18, 2018	Z-2789-2018	—	open, classified	GUANGZHOU WONDFO BIOTECH discovered on the TCube One Step Multi-Drug Oral Fluid Test Cube the potential for failure of the saliva collection device. The use of the saliva collection device could cause the foam tip to become dislodged in the user's mouth creating a choking hazard.
May 18, 2018	Z-2788-2018	—	open, classified	GUANGZHOU WONDFO BIOTECH discovered on the TCube One Step Multi-Drug Oral Fluid Test Cube the potential for failure of the saliva collection device. The use of the saliva collection device could cause the foam tip to become dislodged in the user's mouth creating a choking hazard.
May 18, 2018	Z-2787-2018	—	open, classified	GUANGZHOU WONDFO BIOTECH discovered on the TCube One Step Multi-Drug Oral Fluid Test Cube the potential for failure of the saliva collection device. The use of the saliva collection device could cause the foam tip to become dislodged in the user's mouth creating a choking hazard.