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Guangzhou Wondfo Biotech Co., Ltd.

China·CN-MF-000000689

Last updated September 17, 2026

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)

Page 1 of 4

Device	Model / Reference	Registries	Class	Status
Finecare	W232	EUDAMED	IVD General	Active
Finecare	W262P0001	EUDAMED	IVD General	Active
Finecare	W201P0008	EUDAMED	IVD General	Active
SmarLumi	WA35P0003	EUDAMED	IVD General	Active
SmarLumi	WA12P0008	EUDAMED	IVD General	Active
U-Card™ 200	WR45P0004	EUDAMED	IVD General	Active
Automated Digital Slide Scanning and Analysis System	WK32	EUDAMED	Class A	Active
SmarLumi	WA48P0002	EUDAMED	IVD General	Active
PA-Bluing Reagent	WF33P0001	EUDAMED	Class A	Active
Finecare	W896P0001	EUDAMED	IVD General	Active
Finecare	W209	EUDAMED	IVD Annex II List B	Active
Finecare	W897P0001	EUDAMED	IVD General	Active
SmarLumi	WA31P0004	EUDAMED	IVD General	Active
Finecare	W230	EUDAMED	IVD Annex II List B	Active
Fibrinogen Reagent Kit (Clotting)	W482	EUDAMED	IVD General	Active
Finecare	W812	EUDAMED	IVD General	Active
Finecare	W279P0001	EUDAMED	IVD General	Active
Finecare	W217	EUDAMED	IVD General	Active
Finecare	W269P0001	EUDAMED	IVD General	Active
Finecare	W806	EUDAMED	IVD General	Active
Finecare	W244	EUDAMED	IVD General	Active
Finecare	W221P0004	EUDAMED	IVD General	Active
Blood Gas Analyzer	W957 W956	EUDAMED	Class A	Active
Fully Automated Pathology Staining System	W948	EUDAMED	Class A	Active
Finecare	W298P0001	EUDAMED	IVD General	Active
Blood Gas Analyzer Reagent Pack	W451-Z0P4-I	EUDAMED	IVD General	Active
Finecare	W809	EUDAMED	IVD General	Active
Finecare	W202	EUDAMED	IVD General	Active
Blood Gas Analyzer Test Card	W459-C7P4-E, W461-C7P4-E, W465-C7P4-E, W466-C7P4-E	EUDAMED	IVD General	Active
Finecare	WS01P0001	EUDAMED	IVD General	Active
PA-Immunochromogenic Reagent (Red staining)	WDA9P0001	EUDAMED	Class A	Active
Finecare	W233	EUDAMED	IVD General	Active
Finecare	W250	EUDAMED	IVD General	Active
Finecare	W894P0001	EUDAMED	IVD General	Active
Finecare	W220	EUDAMED	IVD General	Active
Wondfo Optical Coagulation Analyzer	W958	EUDAMED	Class A	Active
Finecare	W231	EUDAMED	IVD General	Active
Automatic Blood Gas Analyzer Solution Pack	W795P0002	EUDAMED	IVD General	Active
Finecare	WS02P0001	EUDAMED	IVD General	Active
Finecare	W200	EUDAMED	IVD General	Active
Finecare	W223	EUDAMED	IVD General	Active
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

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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.

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.