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WONDFO USA CO., LTD.

Last updated September 17, 2026

Information

Country: US
Address: 890 Remington Blvd, Bolingbrook, IL, 60440
Website: wondfousa.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 630-468-2199
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3007606081
DUNS Number: 849098897

Catalogue (417)

Page 2 of 9

Device	Model / Reference	Registries	Class	Status
Wondview	W39-S	FDA UDI	Class I	Active
Wondfo Key Cup	KDOA-3104	FDA UDI	Class II	Active
T-Cup	TDOA-6125A3	FDA UDI	Class II	Active
Prime Screen	DWDCO-114-10BX-A	FDA UDI	Class II	Active
Wondfo Key Cup	KDOA-264	FDA UDI	Class II	Active
Preview	PRE-WDOA-254	FDA UDI	Class II	Active
Preview	PRE-HCG-25SE	FDA UDI	Class II	Active
Wondfo Drug Test Dip Card	WDCO-114	FDA UDI	Class II	Active
Prime Screen	DWDOA-3104-25BX-A	FDA UDI	Class II	Active
Wondfo Drug Test Dip Card	WDOA-564	FDA UDI	Class II	Active
WELLlife™	WL03P0001-1	FDA UDI	Class II	Active
T-Cup	TDOA-254	FDA UDI	Class II	Active
Prime Screen	DSODOA-116-COT-P	FDA UDI	Class I	Active
Wondfo	WS-H10L25-CA	FDA UDI	Class II	Active
Wondfo	SW1-S	FDA UDI	Class II	Active
T-Cup	TDOA-7125	FDA UDI	Class II	Active
WELLlife™	WV01P0001-2S	FDA UDI	N	Active
Wondfo Key Cup	KDOA-254	FDA UDI	Class II	Active
Prime Screen	DWDMA-114-25BX-A	FDA UDI	Class II	Active
Preview Pregnancy Test	W1-MP2	FDA UDI	Class II	Unknown
SAFElife™	CDOA-3104A3	FDA UDI	Class II	Active
Wondfo Drug Test Dip Card	WDOA-754	FDA UDI	Class II	Active
SAFElife™	CDOA-6124	FDA UDI	Class II	Active
Wondfo Drug Test Dip Card	WDOA-865	FDA UDI	Class II	Active
T-Cup Compact	CDOA-L9135NTA3	FDA UDI	Class II	Active
Wondfo	WDOA-3124A	FDA UDI	Class II	Active
T-Cup	TDOA-7125A3	FDA UDI	Class II	Active
T-Cup	TDOA-955	FDA UDI	Class II	Active
Wondfo Drug Test Dip Card	WDBA-114	FDA UDI	Class II	Active
Prime Screen	DTDOA-1144-1BX-A	FDA UDI	U	Active
Wondfo Drug Test Dip Card	WDOA-274	FDA UDI	Class II	Active
Prime Screen	DTDOA-1144-5BX-A	FDA UDI	Class II	Active
Wondfo	W1-M4	FDA UDI	Class II	Active
Wondfo	W2-S50-CA	FDA UDI	Class I	Active
WELLlife™	WL03P0001-10	FDA UDI	Class II	Active
T-Cup	TDOA-654	FDA UDI	Class II	Active
Wondfo Saliva Alcohol Test	W53-S	FDA UDI	Class II	Active
Prime Screen	DWDOA-254-5BX-A	FDA UDI	Class II	Active
Wondfo Drug Test Strip	WDTH-101	FDA UDI	Class II	Active
WELLlife™	WV01P0002-S	FDA UDI	N	Active
T-Cup	TDOA-3104A3	FDA UDI	Class II	Active
T-Square	QODOA-10106EUO-I	FDA UDI	Class II	Active
Wondfo Drug Test Cassette	WDBU-201	FDA UDI	Class II	Active
Wondfo	W1-S25	FDA UDI	Class II	Active
T-Cup	TDOA-654A3	FDA UDI	Class II	Active
T-Cup Compact	CDOA-L6125A3	FDA UDI	Class II	Active
T-Cup	TDOA-744NT	FDA UDI	Class II	Active
Wondfo	SODOA-466EUO	FDA UDI	Class II	Active
T-Cup	TDOA-164	FDA UDI	Class II	Active
T-Cup	TDOA-264A3	FDA UDI	Class II	Active

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FDA Recalls (5)

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
Apr 22, 2024	Z-2031-2024	—	open, classified	Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers.
Apr 22, 2024	Z-2032-2024	—	open, classified	Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers.
Apr 22, 2024	Z-2034-2024	—	open, classified	Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers.
Apr 22, 2024	Z-2033-2024	—	open, classified	Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers.
Apr 22, 2024	Z-2030-2024	—	open, classified	Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers.