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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 (183)

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Device	Model / Reference	Registries	Class	Status
Wondfo Rapid Strep A Test	K133343	FDA 510(k)	Class I	Active
One Step Hcg Urine Pregnancy Test	K043443	FDA 510(k)	Class II	Active
Wondfo Phencyclidine Urine Test, Tricyclic Antidepressants Urine Test	K112395	FDA 510(k)	Class II	Active
CR3 Keyless Split Sample Cup Secobarbital- Methadone	K143535	FDA 510(k)	Class II	Active
Wondfo One Step Buprenorphine Urine Test, Oxycodone Urine Test, Propoxphene Urine Test, Multiple Drug Of Abuse Urine Tes	K093175	FDA 510(k)	Class II	Active
Wondfo Amphetamine Urine Test, Wondfo Barbiturates Urine Test, Wondfo Benzodiazepines Urine Test	K111560	FDA 510(k)	Class II	Active
One Step Multiple Drugs Of Abuse Assays	K050024	FDA 510(k)	Class II	Active
Wondofo Multi-Drug Urine Test Cup / Panel	K130665	FDA 510(k)	Class II	Active
Cannabinoids Urine Test	K110182	FDA 510(k)	Class II	Active
CR3 Keyless Split Sample Cup Morphine - Methamphetamine	K150602	FDA 510(k)	Class II	Active
One Step HCG Urine Test	W1-S	EUDAMED	IVD devices for self-testing	Active
One Step Prostate Specific Antigen (PSA) Serum/Plasma Test	W31-S	EUDAMED	IVD Annex II List B	Active
One Step Influenza A Test	W72-CH	EUDAMED	IVD devices for self-testing	Active
One Step Influenza B Test	W73-CH	EUDAMED	IVD devices for self-testing	Active
One Step Prostate Specific Antigen (PSA) Serum/Plasma Test	W31-C	EUDAMED	IVD Annex II List B	Active
One Step Strep A Swab Test	W039P0001	EUDAMED	IVD devices for self-testing	Active
Easy@Home Ovulation Test	EZW2-S	EUDAMED	IVD devices for self-testing	Active
One Step Influenza A&B Test	W71-CH	EUDAMED	IVD devices for self-testing	Active
Sperm Concentration Test	W121-C	EUDAMED	IVD devices for self-testing	Active
One Step Influenza B Test	W73-SH	EUDAMED	IVD devices for self-testing	Active
One Step HCG Urine Test	W1-M	EUDAMED	IVD devices for self-testing	Active
One Step Influenza A&B Test	W71-SH	EUDAMED	IVD devices for self-testing	Active
Sperm Concentration Test	W121-S	EUDAMED	IVD devices for self-testing	Active
One Step Fecal Occult Blood (FOB)Test	W030-S(50ng/ml)	EUDAMED	IVD devices for self-testing	Active
One Step HCG Urine Test	W1-S (20mIU)	EUDAMED	IVD devices for self-testing	Active
One Step FSH Urine Test	W52-S	EUDAMED	IVD devices for self-testing	Active
One Step HCG Urine Test	W1-M (20mIU)	EUDAMED	IVD devices for self-testing	Active
One Step Prostate Specific Antigen (PSA) Whole Blood/Serum/Plasma Test	W31-S4P	EUDAMED	IVD Annex II List B	Active
One Step Influenza A Test	W72-SH	EUDAMED	IVD devices for self-testing	Active
One Step Strep A Swab Test	W39-CH	EUDAMED	IVD devices for self-testing	Active
Diagnostic Kit for Human IgM Antibody of Chlamydia Pneumoniae (Immunochromatographic Assay)	W135-C	EUDAMED	IVD Annex II List B	Active
One Step Ovulation Urine Test	W2-M	EUDAMED	IVD devices for self-testing	Active
Easy@Home Pregnancy Test	EZW1-S	EUDAMED	IVD devices for self-testing	Active
One Step FSH Urine Test	W52-M	EUDAMED	IVD devices for self-testing	Active
One Step Ovulation Urine Test	W2 –S	EUDAMED	IVD devices for self-testing	Active
One Step Chlamydia Swab / Urine Test	W35-C	EUDAMED	IVD Annex II List B	Active
Finecare™ FPSA (Free Prostate Specific Antigen) Rapid Quantitative Test	W230	EUDAMED	IVD Annex II List B	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.