{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Teratech Corporation. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/teratech-corporation (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/teratech-corporation",
    "json_url": "https://devicerts.com/manufacturers/teratech-corporation.json",
    "markdown_url": "https://devicerts.com/manufacturers/teratech-corporation.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "EUDAMED",
        "url": "https://ec.europa.eu/tools/eudamed"
      },
      {
        "registry": "FDA GUDID",
        "url": "https://accessgudid.nlm.nih.gov/"
      },
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      },
      {
        "registry": "FDA registration and listing",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm"
      }
    ],
    "eudamed_record_synced": "2026-11-07",
    "fda_recalls_as_of": "2026-11-01",
    "registry_facts_computed": "2026-11-15",
    "status_as_of": "2026-11-15",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "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",
    "disclaimer": "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."
  },
  "manufacturer": {
    "name": "Teratech Corporation",
    "url": "https://devicerts.com/manufacturers/teratech-corporation",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [
      "Teratech Corp."
    ],
    "country": "United States",
    "country_basis": "from SRN",
    "eudamed_status": {
      "status": "active",
      "since_year": null
    },
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [
      "EUDAMED",
      "FDA"
    ],
    "identifiers": [
      {
        "label": "EUDAMED SRN",
        "value": "US-MF-000033295"
      },
      {
        "label": "FDA FEI",
        "value": "3002315840"
      },
      {
        "label": "DUNS",
        "value": "836416321"
      }
    ],
    "summary": "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.",
    "noindex": false
  },
  "counts": {
    "devices": 46,
    "devices_note": null,
    "certificates": 1,
    "fda_recalls_matched_by_name": 0,
    "fda_recalls_ongoing": 0,
    "fda_recalls_ongoing_recent": 0,
    "fda_recalls_ongoing_before": null,
    "fda_establishments": 0,
    "sites": 0
  },
  "registry_facts": {
    "covers": "Every device of the manufacturer. A device listed in two registries counts in both.",
    "registries": [
      {
        "registry": "FDA GUDID",
        "devices": 24
      },
      {
        "registry": "FDA 510(k)",
        "devices": 19
      },
      {
        "registry": "EUDAMED",
        "devices": 15
      }
    ],
    "device_classes": [
      {
        "class": "FDA Class II",
        "devices": 32
      },
      {
        "class": "EU Class IIa",
        "devices": 14
      }
    ],
    "top_emdn_categories": [
      {
        "code": "Z11",
        "name": "Bioimaging and radiotherapy instruments",
        "url": "https://devicerts.com/categories/emdn/Z11",
        "devices": 14
      }
    ]
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": [
      {
        "name": "Wellkang Ltd",
        "url": "https://devicerts.com/representatives/wellkang-ltd-xi-ar-000001836",
        "country": "Northern Ireland"
      }
    ]
  },
  "devices": {
    "shown": 46,
    "total": 46,
    "all_devices_url": "https://devicerts.com/manufacturers/teratech-corporation",
    "items": [
      {
        "name": "Terason uSmart3200T",
        "url": "https://devicerts.com/devices/terason-usmart3200t-abf2ebd9",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Terason uSmart3300 Cart",
        "url": "https://devicerts.com/devices/terason-usmart3300-cart",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Terason PDOF",
        "url": "https://devicerts.com/devices/terason-pdof",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Terason uSmart3200T Roller Bag",
        "url": "https://devicerts.com/devices/terason-usmart3200t-roller-b",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Terason uSmart3300",
        "url": "https://devicerts.com/devices/terason-usmart3300",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Terason uSmart3200T Cart",
        "url": "https://devicerts.com/devices/terason-usmart3200t-cart",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Terason uSmart3200T",
        "url": "https://devicerts.com/devices/terason-usmart3200t-2d5b671a",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Terason 8L2",
        "url": "https://devicerts.com/devices/terason-8l2",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Terason 8EC4A",
        "url": "https://devicerts.com/devices/terason-8ec4a",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Terason uSmart3200T MUX",
        "url": "https://devicerts.com/devices/terason-usmart3200t-mux",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Terason uSmart3200T",
        "url": "https://devicerts.com/devices/terason-usmart3200t",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Terason uSmart3300 MUX",
        "url": "https://devicerts.com/devices/terason-usmart3300-mux",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Terason uSmart3300 Roller Bag",
        "url": "https://devicerts.com/devices/terason-usmart3300-roller-ba",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Terason 12L5A",
        "url": "https://devicerts.com/devices/terason-12l5a-10-3276",
        "model_reference": "10-3276",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Terason uSmart3200T USB3",
        "url": "https://devicerts.com/devices/terason-usmart3200t-usb3-10-3232-r200",
        "model_reference": "10-3232 R200",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Terason uSmart3300 Ultrasound System",
        "url": "https://devicerts.com/devices/terason-usmart3300-ultrasound-system-iyn-k150148",
        "model_reference": "K150148",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2015-02-20",
        "open_recall": false
      },
      {
        "name": "Terason USMART3200T Ultrasound System",
        "url": "https://devicerts.com/devices/terason-usmart3200t-ultrasound-system-iyn-k131209",
        "model_reference": "K131209",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2013-05-24",
        "open_recall": false
      },
      {
        "name": "Teratech Model 8IOC4, 8IOL4 & 10LAP4 Probes",
        "url": "https://devicerts.com/devices/teratech-model-8ioc4-8iol4-and-10lap4-probes-itx",
        "model_reference": "K043278",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2004-12-13",
        "open_recall": false
      },
      {
        "name": "Terason Model 2000/Bas Portable Ultrasound System",
        "url": "https://devicerts.com/devices/terason-model-2000-bas-portable-ultrasound-system-iyn",
        "model_reference": "K030191",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2003-01-29",
        "open_recall": false
      },
      {
        "name": "Terason USMART3200 And Benq UP200ULTRASOUND System",
        "url": "https://devicerts.com/devices/terason-usmart3200-and-benq-up200ultrasound-system-iyn",
        "model_reference": "K140524",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2014-03-21",
        "open_recall": false
      },
      {
        "name": "Terason T3200 Ultrasound System",
        "url": "https://devicerts.com/devices/terason-t3200-ultrasound-system-itx",
        "model_reference": "K110020",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2011-01-20",
        "open_recall": false
      },
      {
        "name": "Teratech Model 10V5 Smart Probe",
        "url": "https://devicerts.com/devices/teratech-model-10v5-smart-probe-itx",
        "model_reference": "K040840",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2004-04-14",
        "open_recall": false
      },
      {
        "name": "Terason Ultrasound System With Continuous Wave Soppler",
        "url": "https://devicerts.com/devices/terason-ultrasound-system-with-continuous-wave-soppler-iyn",
        "model_reference": "K051334",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2005-06-03",
        "open_recall": false
      },
      {
        "name": "Terason T3000 Ultrasound Systems With Updated Needle Guidance Graphics",
        "url": "https://devicerts.com/devices/terason-t3000-ultrasound-systems-with-updated-needle-guidanc-iyn",
        "model_reference": "K112953",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2012-02-03",
        "open_recall": false
      },
      {
        "name": "Terason uSmart 3200T Plus Ultrasound System",
        "url": "https://devicerts.com/devices/terason-usmart-3200t-plus-ultrasound-system-iyn",
        "model_reference": "K201633",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2020-07-02",
        "open_recall": false
      },
      {
        "name": "Terason USMART3400 Ultrasound System",
        "url": "https://devicerts.com/devices/terason-usmart3400-ultrasound-system-iyn",
        "model_reference": "K140834",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2014-04-25",
        "open_recall": false
      },
      {
        "name": "Terason uSmart3200T Ultrasound System",
        "url": "https://devicerts.com/devices/terason-usmart3200t-ultrasound-system-iyn-k193510",
        "model_reference": "K193510",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2020-01-28",
        "open_recall": false
      },
      {
        "name": "Terason uSmart3200T Ultrasound System",
        "url": "https://devicerts.com/devices/terason-usmart3200t-ultrasound-system-iyn",
        "model_reference": "K150533",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2015-05-09",
        "open_recall": false
      },
      {
        "name": "Prosound C3 / C3 Cv Ultrasound Systems",
        "url": "https://devicerts.com/devices/prosound-c3-c3-cv-ultrasound-systems-iyn",
        "model_reference": "K110482",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2011-03-18",
        "open_recall": false
      },
      {
        "name": "Terason Echo T/3000 Ultrasound System With Stress Echo",
        "url": "https://devicerts.com/devices/terason-echo-t-3000-ultrasound-system-with-stress-echo-iyo",
        "model_reference": "K080234",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2008-02-14",
        "open_recall": false
      },
      {
        "name": "Teratech, Model 2000 Imaging Imaging",
        "url": "https://devicerts.com/devices/teratech-model-2000-imaging-imaging-iyo",
        "model_reference": "K992505",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1999-11-10",
        "open_recall": false
      },
      {
        "name": "Teratech Model 8EC4 Endocavity Smart Probe",
        "url": "https://devicerts.com/devices/teratech-model-8ec4-endocavity-smart-probe-itx",
        "model_reference": "K010883",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2001-04-06",
        "open_recall": false
      },
      {
        "name": "Terason USMART3300 Ultrasound System",
        "url": "https://devicerts.com/devices/terason-usmart3300-ultrasound-system-iyn",
        "model_reference": "K140773",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2014-05-30",
        "open_recall": false
      },
      {
        "name": "Teratech Model 2000 Handheld Ultrasound System With Doppler And Harmonic Imaging Modes",
        "url": "https://devicerts.com/devices/teratech-model-2000-handheld-ultrasound-system-with-doppler-iyn",
        "model_reference": "K012191",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2001-07-26",
        "open_recall": false
      },
      {
        "name": "Terason XY",
        "url": "https://devicerts.com/devices/terason-xy-10-3363",
        "model_reference": "10-3363",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Terason 9MC3",
        "url": "https://devicerts.com/devices/terason-9mc3-10-3255-r2",
        "model_reference": "10-3255 R2",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Terason 4V2A",
        "url": "https://devicerts.com/devices/terason-4v2a-10-3216",
        "model_reference": "10-3216",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Terason 8V3A",
        "url": "https://devicerts.com/devices/terason-8v3a-10-3329",
        "model_reference": "10-3329",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Terason 15L4",
        "url": "https://devicerts.com/devices/terason-15l4-10-3289",
        "model_reference": "10-3289",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Terason uSmart3300 USB3",
        "url": "https://devicerts.com/devices/terason-usmart3300-usb3-10-3303-r2",
        "model_reference": "10-3303 R2",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Terason 5C2A",
        "url": "https://devicerts.com/devices/terason-5c2a-10-3278",
        "model_reference": "10-3278",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Terason 15L4A",
        "url": "https://devicerts.com/devices/terason-15l4a-10-3378",
        "model_reference": "10-3378",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Terason 16HL7",
        "url": "https://devicerts.com/devices/terason-16hl7-10-3279",
        "model_reference": "10-3279",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Terason 8BP4",
        "url": "https://devicerts.com/devices/terason-8bp4-10-3275",
        "model_reference": "10-3275",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Terason 15WL4",
        "url": "https://devicerts.com/devices/terason-15wl4-10-3390",
        "model_reference": "10-3390",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Terason uSmart3200T Plus",
        "url": "https://devicerts.com/devices/terason-usmart3200t-plus-10-3258",
        "model_reference": "10-3258",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      }
    ]
  },
  "certificates": [
    {
      "number": "28620253687",
      "type": "Quality management system",
      "legislation": "MDR",
      "notified_body": "Intertek Medical Notified Body AB",
      "issued": "2026-08-13",
      "expires": "2031-03-01",
      "status": "issued",
      "no_longer_listed": false
    }
  ],
  "recalls": []
}