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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)

Page 2 of 4

Device	Model / Reference	Registries	Class	Status
Finecare	WW01P0002	EUDAMED	IVD General	Active
Finecare	W246P0001	EUDAMED	IVD General	Active
Finecare	WW11P0001	EUDAMED	IVD General	Active
PA-Immunochromogenic Reagent (Dual staining)	WDB1P0001	EUDAMED	Class A	Active
Finecare	W210	EUDAMED	IVD General	Active
Blood Gas Analyzer Control	W848	EUDAMED	IVD General	Active
Finecare	WS12P0001	EUDAMED	IVD General	Active
Activated Clotting Time Reagent Kit (Clotting)	W483	EUDAMED	IVD General	Active
Finecare	W914	EUDAMED	IVD General	Active
PA-Enhancer(Linker)	WDA8P0001	EUDAMED	Class A	Active
Finecare	W814	EUDAMED	IVD Annex II List B	Active
Finecare	W895P0001	EUDAMED	IVD General	Active
Finecare	W828	EUDAMED	IVD General	Active
Finecare	W825P0001	EUDAMED	IVD General	Active
PA-Immunochromogenic Reagent	WF15P0001	EUDAMED	Class A	Active
Blood Gas Analyzer Control	W905P0004	EUDAMED	IVD General	Active
Finecare	W257P0001	EUDAMED	IVD General	Active
Finecare	W204	EUDAMED	IVD General	Active
Prothrombin Time Reagent Kit (Clotting)	W480	EUDAMED	IVD General	Active
Finecare	W254P0001	EUDAMED	IVD General	Active
Finecare	W815	EUDAMED	IVD General	Active
Finecare	W248-C4P1-E	EUDAMED	IVD General	Active
Finecare	WS04P0001	EUDAMED	IVD General	Active
PA-Sample Release Reagent	WF16P0001	EUDAMED	Class A	Active
Finecare	W270P0001	EUDAMED	IVD General	Active
Finecare	W247-C4P1-E	EUDAMED	IVD General	Active
Finecare	W873P0001	EUDAMED	IVD General	Active
Finecare	W225	EUDAMED	IVD General	Active
Blood Gas Analyzer Control	W849-L	EUDAMED	IVD General	Active
Finecare	W810	EUDAMED	IVD General	Active
Thrombin Time Reagent Kit (Clotting)	W484	EUDAMED	IVD General	Active
Finecare	W841P0001	EUDAMED	IVD General	Active
Finecare	W241P0008	EUDAMED	IVD General	Active
Finecare	W805	EUDAMED	IVD General	Active
Finecare	W211	EUDAMED	IVD General	Active
Activated Partial Thromboplastin Time Reagent Kit (Clotting)	W481	EUDAMED	IVD General	Active
Finecare	W910	EUDAMED	Class A	Active
Finecare	W862P0001	EUDAMED	IVD General	Active
lood Gas Analyzer Control	W905P0005	EUDAMED	IVD General	Active
Finecare	W911	EUDAMED	IVD General	Active
Finecare	W203	EUDAMED	IVD General	Active
Finecare	W208	EUDAMED	IVD General	Active
Finecare	W251P0001	EUDAMED	IVD General	Active
Finecare	WX01P0001	EUDAMED	IVD General	Active
Finecare	W808	EUDAMED	IVD General	Active
Finecare	W819	EUDAMED	IVD General	Active
Finecare	W872P0001	EUDAMED	IVD General	Active
Finecare	W915	EUDAMED	IVD General	Active
Finecare	W228	EUDAMED	IVD General	Active
Finecare	W218	EUDAMED	IVD General	Active

Related Companies

Authorised Representatives

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Importers

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Notified Bodies

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Authorities

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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.