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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 1 of 9

Device	Model / Reference	Registries	Class	Status
T-Square	QODOA-166EUO	FDA UDI	Class II	Active
SAFElife™	CDOA-2135	FDA UDI	Class II	Active
Prime Screen	DQODOA-376EUO-I-25BX-A	FDA UDI	Class II	Active
Wondfo Drug Test Dip Card	WDOX-114	FDA UDI	Class II	Active
Prime Screen	DTDOA-1144-25BX-A	FDA UDI	Class II	Active
T-Cup Compact	CDOA-3124	FDA UDI	Class II	Active
Wondfo Key Cup	KDOA-7104	FDA UDI	Class II	Active
Wondfo	SW2-C	FDA UDI	Class I	Active
Wondfo Drug Test Dip Card	WDOA-6125	FDA UDI	Class II	Active
WELLlife™	WV01P0003	FDA UDI	N	Active
Prime Screen	DCDOA-6125-2BX-A	FDA UDI	Class II	Active
T-Square	QODOA-156EUO-I	FDA UDI	Class II	Active
Preview Pregnancy Test	W1-MP3	FDA UDI	Class II	Unknown
T-Cup	TDOA-154	FDA UDI	Class II	Active
Wondfo	WS-H10L40	FDA UDI	Class II	Active
Wondfo	CRDOA-6125	FDA UDI	Class II	Active
PrimeScreen	DWDOA-264-5B-B	FDA UDI	Class II	Active
Preview	PRE-PDOA-755	FDA UDI	Class II	Active
Wondfo	SODOA-666EUO	FDA UDI	Class II	Active
Wondfo	CDOA-6125	FDA UDI	Class II	Active
Preview	PRE-FIT-25KIT	FDA UDI	Class II	Active
Wondfo Pregnancy Test	W1-C	FDA UDI	Class II	Active
Wondfo Drug Test Dip Card	WDOA-154	FDA UDI	Class II	Active
Wondfo Drug Test Dip Card	WDOA-4104	FDA UDI	Class II	Active
Wondfo Drug Test Dip Card	WDBA-114	FDA UDI	Class II	Active
T-Cup	TDOA-2135A3	FDA UDI	Class II	Active
Wondfo Drug Test Dip Card	WDOA-564	FDA UDI	Class II	Active
Wondfo Drug Test Dip Card	WDOA-565	FDA UDI	Class II	Active
T-Cup	TDOA-7104A3	FDA UDI	Class II	Active
Prime Screen	DTDOA-6125-2BX-A	FDA UDI	Class II	Active
SAFElife™	DCDOA-564-5BX-A	FDA UDI	Class II	Active
Wondfo	WS-H20L50-CA	FDA UDI	Class II	Active
WELLlife™	WCOVFLU-OTC-2	FDA UDI	Class II	Active
Preview	PRE-WDOA-232	FDA UDI	Class II	Active
T-Square	QODOA-966EUO-I	FDA UDI	Class II	Active
WELLlife™	WCOVFLU-OTC-10	FDA UDI	Class II	Active
T-Cup	TDOA-3124	FDA UDI	Class II	Active
T-Dip	WDOA-334	FDA UDI	Class II	Active
Wondfo Drug Test Dip Card	WDOA-654	FDA UDI	Class II	Active
T-Cup	TDOA-1144A3	FDA UDI	Class II	Active
WELLlife™	WL03P0001-2S	FDA UDI	Class II	Active
Preview	PRE-PDOA-6125	FDA UDI	Class II	Active
T-Cup	TDOA-4105A3	FDA UDI	Class II	Active
Prime Screen	DWDOA-6125-25BX-A	FDA UDI	Class II	Active
Wondfo	DW199-S-6BX-A	FDA UDI	Class I	Active
T-Cup	TDOA-SVTV	FDA UDI	Class I	Active
WELLlife™	WFLUAB-OTC-25	FDA UDI	Class II	Active
Bsure	CDOA-6125	FDA UDI	Class II	Active
T-Cup	TDOA-6125	FDA UDI	Class II	Active
Wondfo Drug Test Dip Card	WDMO-114	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.