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WONDFO USA CO., LTD.

Last updated September 17, 2026

What WONDFO USA CO., LTD. makes

The company manufactures in vitro diagnostic (IVD) devices for detecting drugs of abuse, human chorionic gonadotropin (hCG), fentanyl, SARS-CoV-2 antigen, luteinizing hormone (LH), and multiple-genus respiratory viruses. Products include rapid immunoassay kits, self-testing devices, and clinical test formats, as well as natural conception assistance kits. Examples include dip cards, compact test cups, and rapid screening devices for point-of-care and home use.

These devices are regulated under FDA’s In Vitro Diagnostic Device (IVD) classification system, including Class I and Class II devices, as well as non-classified (N) and unclassified (U) products. They are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.

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 Wondfo USA Co., Ltd. manufacture?

Wondfo USA Co., Ltd. specializes in in vitro diagnostic (IVD) devices. Their products primarily focus on detecting substances like drugs of abuse, human chorionic gonadotropin (hCG), fentanyl, SARS-CoV-2 antigen, luteinizing hormone (LH), and multiple-genus respiratory viruses. These devices come in various formats, including rapid immunoassay kits, self-testing devices, and clinical test kits. They also produce natural conception assistance kits, catering to both point-of-care and home testing needs.

Where is Wondfo USA Co., Ltd. based?

Wondfo USA Co., Ltd. is based in the United States. This location allows them to align with U.S. regulatory requirements, including those for in vitro diagnostic devices.

Which regulatory registries list Wondfo USA Co., Ltd.’s devices?

Wondfo USA Co., Ltd.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for authorized IVD products, including those classified under the FDA’s system.

How are Wondfo USA Co., Ltd.’s devices classified under FDA regulations?

Wondfo USA Co., Ltd.’s devices fall under the FDA’s In Vitro Diagnostic Device (IVD) classification system. Their products are categorized as Class I, Class II, non-classified (N), or unclassified (U) based on their risk levels and intended use. For example, lower-risk devices like some rapid test kits may be Class I, while higher-risk or more complex diagnostics could be Class II. The classification determines regulatory oversight and submission requirements.

What kinds of testing formats do Wondfo USA Co., Ltd.’s IVD devices include?

Wondfo USA Co., Ltd.’s IVD devices include rapid immunoassay kits designed for point-of-care and home use, such as dip cards (e.g., *Wondfo Drug Test Dip Card*), compact test cups (e.g., *T-Cup Compact*), and self-testing formats for detecting substances like SARS-CoV-2 antigen or respiratory viruses. Clinical versions are also available for laboratory settings, ensuring flexibility across different testing environments.

AI-generated from registry data and not verified by a human reviewer.

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 6 of 9

Device	Model / Reference	Registries	Class	Status
PrimeScreen	DWDTH-114-15BX-A	FDA UDI	Class II	Active
T-Square	QODOA-496EUO-I	FDA UDI	Class II	Active
Wondfo	W1-S20	FDA UDI	Class II	Active
WELLlife™	WCOVFLU-POC-10	FDA UDI	Class II	Active
Wondfo	WE03P0014	FDA UDI	Class I	Active
Preview	PRE-PDOA-274	FDA UDI	Class II	Active
Wondfo Drug Test Dip Card	WDOA-654	FDA UDI	Class II	Active
Wondfo Drug Test Dip Card	WDOA-154	FDA UDI	Class II	Active
Wondfo Drug Test Dip Card	WDOA-144	FDA UDI	Class II	Active
Wondfo Drug Test Dip Card	WDOA-274	FDA UDI	Class II	Active
SAFElife™	CDOA-264	FDA UDI	Class II	Active
WELLlife™	WV01P0001-1	FDA UDI	N	Active
WELLlife™	WCOV-POC-25	FDA UDI	Class II	Active
T-Cup	TDOA-3124	FDA UDI	Class II	Active
Wondfo	W1-S25-AC	FDA UDI	Class II	Active
T-Square	QODOA-166EUO-I	FDA UDI	Class II	Active
Wondfo Drug Test Dip Card	WDOA-6124	FDA UDI	Class II	Active
Wondfo	DW199-S-5BX-A	FDA UDI	Class I	Active
Wondfo Drug Test Dip Card	WDMA-114	FDA UDI	Class II	Active
WELLlife™	WL03P0001-25	FDA UDI	Class II	Active
T-Cup	TDOA-6124	FDA UDI	Class II	Active
Wondfo Drug Test Dip Card	WDOA-164	FDA UDI	Class II	Active
Preview	PRE-PDOA-6124A3	FDA UDI	Class II	Active
T-Cup	TDOA-3104	FDA UDI	Class II	Active
T-Cup	TDOA-4124	FDA UDI	Class II	Active
T-Cup	TDOA-564	FDA UDI	Class II	Active
SAFElife™	CDOA-1145A3	FDA UDI	U	Active
T-Cup	TDOA-2135A3	FDA UDI	Class II	Active
T-Cup	TDOA-7125	FDA UDI	Class II	Active
Wondfo	DW1-S	FDA UDI	Class II	Active
Wondfo	WS-H5L20	FDA UDI	Class II	Active
SAFElife™	DWFTY-OTC1-10BX	FDA UDI	Class II	Active
Preview	PRE-HCG-25C	FDA UDI	Class II	Active
PrimeScreen	DODOA-256-EUO-25BX-B	FDA UDI	Class II	Active
WELLlife™	WCOVFLU-POC-25S	FDA UDI	Class II	Active
Wondfo Drug Test Dip Card	WDOA-354	FDA UDI	Class II	Active
Wondfo Drug Test Dip Card	WDOA-7125	FDA UDI	Class II	Active
Preview	PRE-WDOA-6124	FDA UDI	Class II	Active
Wondfo Drug Test Strip	WDTH-101	FDA UDI	Class II	Active
Preview	PRE-THC-10BX	FDA UDI	Class II	Active
Prime Screen	DWDOA-264-10BX-A	FDA UDI	Class II	Active
SAFElife™	CDOA-1144A3	FDA UDI	Class II	Active
Wondfo	W2-S25-CA	FDA UDI	Class I	Active
T-Cup	TDOA-6125V	FDA UDI	Class II	Active
SAFElife™	DWFTY-OTC1-25BX	FDA UDI	Class II	Active
T-Cup	TDOA-6124A3	FDA UDI	Class II	Active
Wondfo	DW1-M-DW	FDA UDI	Class II	Active
T-Cup	TDOA-654A3	FDA UDI	Class II	Active
Wondfo	CDOA-8105	FDA UDI	Class II	Active
HORMONElife™	DW199-S-12BX-H	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

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Notified Bodies

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Authorities

Not available yet.

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.

Wondfo USA Co., Ltd. has five recall records, all initiated on April 22, 2024. The records include both open and classified statuses, with the sole reason cited being the unauthorized distribution of the Preview Strep A Test Kit, including sales and distribution for at-home, non-prescription, over-the-counter, or direct-to-consumer use.

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
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.