# Teratech Corporation

> Medical device manufacturer record on deviCERTS, compiled from public registries. Teratech Corporation is a medical device manufacturer based in the United States, with 46 devices listed in FDA GUDID, FDA 510(k) and EUDAMED (FDA Class II; EU Class IIa) as of 15 Nov 2026.

- Canonical page: <https://devicerts.com/manufacturers/teratech-corporation>
- Also registered as: Teratech Corp.
- Country: United States (from SRN)
- EUDAMED actor status: active
- Role: Manufacturer
- Registrations: EUDAMED, FDA
- EUDAMED SRN: US-MF-000033295
- FDA FEI: 3002315840
- DUNS: 836416321

## Figures

- Devices: 46
- EU certificates: 1
- FDA recalls (matched to the firm by name): 0

## Registry facts

*Every device of the manufacturer. A device listed in two registries counts in both.*

- Registries: FDA GUDID 24, FDA 510(k) 19, EUDAMED 15
- Device classes: FDA Class II 32, EU Class IIa 14
- EMDN [Z11 Bioimaging and radiotherapy instruments](https://devicerts.com/categories/emdn/Z11): 14 devices

## Sites and related companies

- Authorised representative: [Wellkang Ltd](https://devicerts.com/representatives/wellkang-ltd-xi-ar-000001836) (Northern Ireland)

## Devices

The first 46 of 46, in the order of the canonical page, which lists them all.

- [Terason uSmart3200T](https://devicerts.com/devices/terason-usmart3200t-abf2ebd9) · Class II · GUDID · status: Listed
- [Terason uSmart3300 Cart](https://devicerts.com/devices/terason-usmart3300-cart) · Class II · GUDID · status: Listed
- [Terason PDOF](https://devicerts.com/devices/terason-pdof) · Class II · GUDID · status: Listed
- [Terason uSmart3200T Roller Bag](https://devicerts.com/devices/terason-usmart3200t-roller-b) · Class II · GUDID · status: Listed
- [Terason uSmart3300](https://devicerts.com/devices/terason-usmart3300) · Class II · EUDAMED, GUDID · status: Active
- [Terason uSmart3200T Cart](https://devicerts.com/devices/terason-usmart3200t-cart) · Class II · GUDID · status: Listed
- [Terason uSmart3200T](https://devicerts.com/devices/terason-usmart3200t-2d5b671a) · Class II · GUDID · status: Listed
- [Terason 8L2](https://devicerts.com/devices/terason-8l2) · Class II · GUDID · status: Listed
- [Terason 8EC4A](https://devicerts.com/devices/terason-8ec4a) · Class II · GUDID · status: Listed
- [Terason uSmart3200T MUX](https://devicerts.com/devices/terason-usmart3200t-mux) · Class II · GUDID · status: Listed
- [Terason uSmart3200T](https://devicerts.com/devices/terason-usmart3200t) · Class II · GUDID · status: Listed
- [Terason uSmart3300 MUX](https://devicerts.com/devices/terason-usmart3300-mux) · Class II · GUDID · status: Listed
- [Terason uSmart3300 Roller Bag](https://devicerts.com/devices/terason-usmart3300-roller-ba) · Class II · GUDID · status: Listed
- [Terason 12L5A](https://devicerts.com/devices/terason-12l5a-10-3276) · ref 10-3276 · Class IIa · EUDAMED, GUDID · status: Active
- [Terason uSmart3200T USB3](https://devicerts.com/devices/terason-usmart3200t-usb3-10-3232-r200) · ref 10-3232 R200 · Class IIa · EUDAMED, GUDID · status: Active
- [Terason uSmart3300 Ultrasound System](https://devicerts.com/devices/terason-usmart3300-ultrasound-system-iyn-k150148) · ref K150148 · Class II · 510(k) · status: Active · decision 2015-02-20
- [Terason USMART3200T Ultrasound System](https://devicerts.com/devices/terason-usmart3200t-ultrasound-system-iyn-k131209) · ref K131209 · Class II · 510(k) · status: Active · decision 2013-05-24
- [Teratech Model 8IOC4, 8IOL4 & 10LAP4 Probes](https://devicerts.com/devices/teratech-model-8ioc4-8iol4-and-10lap4-probes-itx) · ref K043278 · Class II · 510(k) · status: Active · decision 2004-12-13
- [Terason Model 2000/Bas Portable Ultrasound System](https://devicerts.com/devices/terason-model-2000-bas-portable-ultrasound-system-iyn) · ref K030191 · Class II · 510(k) · status: Active · decision 2003-01-29
- [Terason USMART3200 And Benq UP200ULTRASOUND System](https://devicerts.com/devices/terason-usmart3200-and-benq-up200ultrasound-system-iyn) · ref K140524 · Class II · 510(k) · status: Active · decision 2014-03-21
- [Terason T3200 Ultrasound System](https://devicerts.com/devices/terason-t3200-ultrasound-system-itx) · ref K110020 · Class II · 510(k) · status: Active · decision 2011-01-20
- [Teratech Model 10V5 Smart Probe](https://devicerts.com/devices/teratech-model-10v5-smart-probe-itx) · ref K040840 · Class II · 510(k) · status: Active · decision 2004-04-14
- [Terason Ultrasound System With Continuous Wave Soppler](https://devicerts.com/devices/terason-ultrasound-system-with-continuous-wave-soppler-iyn) · ref K051334 · Class II · 510(k) · status: Active · decision 2005-06-03
- [Terason T3000 Ultrasound Systems With Updated Needle Guidance Graphics](https://devicerts.com/devices/terason-t3000-ultrasound-systems-with-updated-needle-guidanc-iyn) · ref K112953 · Class II · 510(k) · status: Active · decision 2012-02-03
- [Terason uSmart 3200T Plus Ultrasound System](https://devicerts.com/devices/terason-usmart-3200t-plus-ultrasound-system-iyn) · ref K201633 · Class II · 510(k) · status: Active · decision 2020-07-02
- [Terason USMART3400 Ultrasound System](https://devicerts.com/devices/terason-usmart3400-ultrasound-system-iyn) · ref K140834 · Class II · 510(k) · status: Active · decision 2014-04-25
- [Terason uSmart3200T Ultrasound System](https://devicerts.com/devices/terason-usmart3200t-ultrasound-system-iyn-k193510) · ref K193510 · Class II · 510(k) · status: Active · decision 2020-01-28
- [Terason uSmart3200T Ultrasound System](https://devicerts.com/devices/terason-usmart3200t-ultrasound-system-iyn) · ref K150533 · Class II · 510(k) · status: Active · decision 2015-05-09
- [Prosound C3 / C3 Cv Ultrasound Systems](https://devicerts.com/devices/prosound-c3-c3-cv-ultrasound-systems-iyn) · ref K110482 · Class II · 510(k) · status: Active · decision 2011-03-18
- [Terason Echo T/3000 Ultrasound System With Stress Echo](https://devicerts.com/devices/terason-echo-t-3000-ultrasound-system-with-stress-echo-iyo) · ref K080234 · Class II · 510(k) · status: Active · decision 2008-02-14
- [Teratech, Model 2000 Imaging Imaging](https://devicerts.com/devices/teratech-model-2000-imaging-imaging-iyo) · ref K992505 · Class II · 510(k) · status: Active · decision 1999-11-10
- [Teratech Model 8EC4 Endocavity Smart Probe](https://devicerts.com/devices/teratech-model-8ec4-endocavity-smart-probe-itx) · ref K010883 · Class II · 510(k) · status: Active · decision 2001-04-06
- [Terason USMART3300 Ultrasound System](https://devicerts.com/devices/terason-usmart3300-ultrasound-system-iyn) · ref K140773 · Class II · 510(k) · status: Active · decision 2014-05-30
- [Teratech Model 2000 Handheld Ultrasound System With Doppler And Harmonic Imaging Modes](https://devicerts.com/devices/teratech-model-2000-handheld-ultrasound-system-with-doppler-iyn) · ref K012191 · Class II · 510(k) · status: Active · decision 2001-07-26
- [Terason XY](https://devicerts.com/devices/terason-xy-10-3363) · ref 10-3363 · Class IIa · EUDAMED · status: Active
- [Terason 9MC3](https://devicerts.com/devices/terason-9mc3-10-3255-r2) · ref 10-3255 R2 · Class IIa · EUDAMED, GUDID · status: Active
- [Terason 4V2A](https://devicerts.com/devices/terason-4v2a-10-3216) · ref 10-3216 · Class IIa · EUDAMED, GUDID · status: Active
- [Terason 8V3A](https://devicerts.com/devices/terason-8v3a-10-3329) · ref 10-3329 · Class IIa · EUDAMED, GUDID · status: Active
- [Terason 15L4](https://devicerts.com/devices/terason-15l4-10-3289) · ref 10-3289 · Class IIa · EUDAMED, GUDID · status: Active
- [Terason uSmart3300 USB3](https://devicerts.com/devices/terason-usmart3300-usb3-10-3303-r2) · ref 10-3303 R2 · Class IIa · EUDAMED · status: Active
- [Terason 5C2A](https://devicerts.com/devices/terason-5c2a-10-3278) · ref 10-3278 · Class IIa · EUDAMED, GUDID · status: Active
- [Terason 15L4A](https://devicerts.com/devices/terason-15l4a-10-3378) · ref 10-3378 · Class IIa · EUDAMED, GUDID · status: Active
- [Terason 16HL7](https://devicerts.com/devices/terason-16hl7-10-3279) · ref 10-3279 · Class IIa · EUDAMED, GUDID · status: Active
- [Terason 8BP4](https://devicerts.com/devices/terason-8bp4-10-3275) · ref 10-3275 · Class IIa · EUDAMED, GUDID · status: Active
- [Terason 15WL4](https://devicerts.com/devices/terason-15wl4-10-3390) · ref 10-3390 · Class IIa · EUDAMED · status: Active
- [Terason uSmart3200T Plus](https://devicerts.com/devices/terason-usmart3200t-plus-10-3258) · ref 10-3258 · Class IIa · EUDAMED, GUDID · status: Active

## EU certificates

- 28620253687 · Quality management system · MDR · notified body Intertek Medical Notified Body AB · issued 2026-08-13 · expires 2031-03-01 · status: issued

## Source and citation

- Cite as: Teratech Corporation. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/teratech-corporation (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID](https://accessgudid.nlm.nih.gov/), [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA registration and listing](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm)
- EUDAMED record synced: 2026-11-07
- FDA recall data as of: 2026-11-01
- Data as of: 2026-11-15
- JSON: <https://devicerts.com/manufacturers/teratech-corporation.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/manufacturers/teratech-corporation
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.