{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "SPECLIPSE, Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/speclipse-inc (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/speclipse-inc",
    "json_url": "https://devicerts.com/manufacturers/speclipse-inc.json",
    "markdown_url": "https://devicerts.com/manufacturers/speclipse-inc.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": "2026-11-14",
    "status_as_of": "2026-11-14",
    "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/speclipse-inc",
    "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": "SPECLIPSE, Inc.",
    "url": "https://devicerts.com/manufacturers/speclipse-inc",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [],
    "country": "South Korea",
    "country_basis": "from SRN",
    "eudamed_status": {
      "status": "active",
      "since_year": null
    },
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [
      "EUDAMED",
      "FDA"
    ],
    "identifiers": [
      {
        "label": "EUDAMED SRN",
        "value": "KR-MF-000026775"
      },
      {
        "label": "FDA FEI",
        "value": "3013697074"
      },
      {
        "label": "DUNS",
        "value": "694509874"
      }
    ],
    "summary": "SPECLIPSE, Inc. is a medical device manufacturer based in South Korea, with 8 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II; EU Class IIb and IIa) as of 14 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 8,
    "devices_note": null,
    "certificates": 0,
    "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": 6
      },
      {
        "registry": "EUDAMED",
        "devices": 5
      },
      {
        "registry": "FDA 510(k)",
        "devices": 1
      }
    ],
    "device_classes": [
      {
        "class": "FDA Class II",
        "devices": 5
      },
      {
        "class": "EU Class IIb",
        "devices": 2
      },
      {
        "class": "EU Class IIa",
        "devices": 1
      }
    ],
    "top_emdn_categories": [
      {
        "code": "Z12",
        "name": "Instruments for functional explorations and therapeutic interventions",
        "url": "https://devicerts.com/categories/emdn/Z12",
        "devices": 2
      },
      {
        "code": "V90",
        "name": "Various devices not included in other classes",
        "url": "https://devicerts.com/categories/emdn/V90",
        "devices": 1
      }
    ]
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": [
      {
        "name": "Qualrep Services B.V.",
        "url": "https://devicerts.com/representatives/qualrep-services-bv-nl-ar-000000537",
        "country": "Netherlands"
      }
    ]
  },
  "devices": {
    "shown": 8,
    "total": 8,
    "all_devices_url": "https://devicerts.com/manufacturers/speclipse-inc",
    "items": [
      {
        "name": "Qmode 01",
        "url": "https://devicerts.com/devices/qmode-01",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Picofy 01",
        "url": "https://devicerts.com/devices/picofy-01",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pico Shining(Picofy) 01",
        "url": "https://devicerts.com/devices/pico-shining-picofy-01",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pico Shining(Pico-K) 01",
        "url": "https://devicerts.com/devices/pico-shining-pico-k-01",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pico Shining (Pico-K; Picofy)",
        "url": "https://devicerts.com/devices/pico-shining-pico-k-picofy-gex",
        "model_reference": "K261214",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2026-05-11",
        "open_recall": false
      },
      {
        "name": "Pico-K",
        "url": "https://devicerts.com/devices/pico-k-pk",
        "model_reference": "PK",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Spectra-Scope Standalone",
        "url": "https://devicerts.com/devices/spectra-scope-standalone-spcs-ifu-sp03-ce",
        "model_reference": "SPCS-IFU-SP03(CE)",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Bellus-Q",
        "url": "https://devicerts.com/devices/bellus-q-bq",
        "model_reference": "BQ",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      }
    ]
  },
  "certificates": [],
  "recalls": []
}