Eterbio, Inc.
ChinaFDA applicant, unverified FDA FEI 3032147516
Eterbio, Inc. is a medical device manufacturer, with 10 devices listed in FDA GUDID and FDA 510(k) (FDA Class II and I) as of 13 Nov 2026.
- Devices
- 10
- Registrations
- FDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 9
- FDA 510(k) 1
- Device classes
- FDA Class II 8
- FDA Class I 2
- Identifiers
- FDA FEI 3032147516
- DUNS 638595825
At a glance
Market reach
- United States
- FDA FEI
What Eterbio, Inc. makes
Eterbio, Inc. manufactures in-vitro diagnostics (IVDs) for detecting drugs of abuse, including multi-drug test cups, rapid immunoassay test kits, and dip cards. Products target oral fluid and clinical samples, covering substances such as cotinine, cannabinoids, and fentanyl/norfentanyl. Formats include colloidal gold-based assays for rapid point-of-care or home testing.
The company’s portfolio includes Class I and Class II devices, regulated under FDA pathways such as 510(k) submissions and the Unique Device Identifier (UDI) system. Devices are listed in the FDA’s regulatory databases, reflecting compliance with U.S. medical device requirements. The manufacturer operates from the United States.
Catalogue
- Regimes: 510(k) Registry: GUDID
- Registry: GUDID
- Regimes: 510(k) Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Regimes: 510(k) Registry: GUDID
- Regimes: 510(k) Registry: GUDID
- Registry: GUDID
- Regimes: 510(k) Registry: GUDID
ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test Ref K243064
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3032147516
- DUNS number
- 638595825
- Address
- Office 420, No. 1316, Caixia Street, Hengqin, Zhuhai City, Guangdong Province, China, Zhuhai Guangdong
Frequently asked questions
How many devices does Eterbio, Inc. have in the registry?
The registry currently lists 10 devices for Eterbio, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Eterbio, Inc.'s devices?
Among its 10 most recently registered devices, Eterbio, Inc. has devices listed in FDA 510(k) (1 device) and FDA GUDID (9 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Eterbio, Inc.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Eterbio, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Eterbio, Inc. in the registry?
The most recently registered devices listed for Eterbio, Inc. include ETERBIO Fentanyl/Norfentanyl Home Test ETG001003, S-Trust SE Oral Fluid Multi-Drug Test Cup(Colloidal Gold) ETG019005, U-Catch PLUS Multi-Drug Test Cup(Colloidal Gold) ETG004005 and U-Catch Cotinine (COT) Test Dip Card(Colloidal Gold) ETG022010.