{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Timpel S/A. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/timpel-s-a (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/timpel-s-a",
    "json_url": "https://devicerts.com/manufacturers/timpel-s-a.json",
    "markdown_url": "https://devicerts.com/manufacturers/timpel-s-a.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/timpel-s-a",
    "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": "Timpel S/A",
    "url": "https://devicerts.com/manufacturers/timpel-s-a",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [],
    "country": "Brazil",
    "country_basis": "from SRN",
    "eudamed_status": {
      "status": "active",
      "since_year": null
    },
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [
      "EUDAMED",
      "FDA"
    ],
    "identifiers": [
      {
        "label": "EUDAMED SRN",
        "value": "BR-MF-000015742"
      },
      {
        "label": "FDA FEI",
        "value": "3013853674"
      },
      {
        "label": "DUNS",
        "value": "897939320"
      }
    ],
    "summary": "Timpel S/A is a medical device manufacturer based in Brazil, with 129 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II; EU Class I and IIa) as of 15 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 129,
    "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": 105
      },
      {
        "registry": "EUDAMED",
        "devices": 78
      },
      {
        "registry": "FDA 510(k)",
        "devices": 3
      }
    ],
    "device_classes": [
      {
        "class": "FDA Class II",
        "devices": 100
      },
      {
        "class": "EU Class I",
        "devices": 26
      },
      {
        "class": "EU Class IIa",
        "devices": 3
      }
    ],
    "top_emdn_categories": [
      {
        "code": "V90",
        "name": "Various devices not included in other classes",
        "url": "https://devicerts.com/categories/emdn/V90",
        "devices": 22
      },
      {
        "code": "A07",
        "name": "Adapters, connectors, ramps, stopcocks, caps",
        "url": "https://devicerts.com/categories/emdn/A07",
        "devices": 3
      },
      {
        "code": "Z11",
        "name": "Bioimaging and radiotherapy instruments",
        "url": "https://devicerts.com/categories/emdn/Z11",
        "devices": 3
      },
      {
        "code": "V80",
        "name": "Clinical use accessories not included in other classes",
        "url": "https://devicerts.com/categories/emdn/V80",
        "devices": 1
      }
    ]
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": []
  },
  "devices": {
    "shown": 50,
    "total": 129,
    "all_devices_url": "https://devicerts.com/manufacturers/timpel-s-a",
    "items": [
      {
        "name": "ENLIGHT Disposable Belt - Size N3",
        "url": "https://devicerts.com/devices/enlight-disposable-belt-size-n3-ace-00005-0",
        "model_reference": "ACE-00005-0",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "ENLIGHT Reference Cable",
        "url": "https://devicerts.com/devices/enlight-reference-cable-dx-0tc03-1",
        "model_reference": "DX-0TC03-1",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "ENLIGHT Disposable Belt - Size N0",
        "url": "https://devicerts.com/devices/enlight-disposable-belt-size-n0-ace-00002-0",
        "model_reference": "ACE-00002-0",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Neonatal Cable",
        "url": "https://devicerts.com/devices/neonatal-cable-ace-cah000p0",
        "model_reference": "ACE-CAH000P0",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "ENLIGHT Disposable Belt - Size N5",
        "url": "https://devicerts.com/devices/enlight-disposable-belt-size-n5-ace-00007-0",
        "model_reference": "ACE-00007-0",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Sensor Belt - Pair - Size P4",
        "url": "https://devicerts.com/devices/sensor-belt-pair-size-p4-ace-bfl0p4p0",
        "model_reference": "ACE-BFL0P4P0",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Sensor Belt - Pair - Size XS",
        "url": "https://devicerts.com/devices/sensor-belt-pair-size-xs-ace-bfl0a0p0",
        "model_reference": "ACE-BFL0A0P0",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Sensor Belt - Pair- Size P3",
        "url": "https://devicerts.com/devices/sensor-belt-pair-size-p3-ace-bfl0p3p0",
        "model_reference": "ACE-BFL0P3P0",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Sensor Belt - Pair - Size P2",
        "url": "https://devicerts.com/devices/sensor-belt-pair-size-p2-ace-bfl0p2p0",
        "model_reference": "ACE-BFL0P2P0",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Sensor Belt - Pair - Size L",
        "url": "https://devicerts.com/devices/sensor-belt-pair-size-l-ace-bfl0a3p0",
        "model_reference": "ACE-BFL0A3P0",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "ENLIGHT Disposable Belt - Size N4",
        "url": "https://devicerts.com/devices/enlight-disposable-belt-size-n4-ace-00006-0",
        "model_reference": "ACE-00006-0",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Elisa VIT Module",
        "url": "https://devicerts.com/devices/elisa-vit-module-tpl-ml000-0",
        "model_reference": "TPL-ML000-0",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Sensor Belt - Pair - Size M",
        "url": "https://devicerts.com/devices/sensor-belt-pair-size-m-ace-bfl0a2p0",
        "model_reference": "ACE-BFL0A2P0",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Neonatal Cable - Pair",
        "url": "https://devicerts.com/devices/neonatal-cable-pair-ace-cal000p0",
        "model_reference": "ACE-CAL000P0",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Enlight 2100",
        "url": "https://devicerts.com/devices/enlight-2100-tpl-e2100-1",
        "model_reference": "TPL-E2100-1",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Sensor Belt - Pair - Size P0",
        "url": "https://devicerts.com/devices/sensor-belt-pair-size-p0-ace-bfl0p0p0",
        "model_reference": "ACE-BFL0P0P0",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "ENLIGHT Adapter Cable - Right",
        "url": "https://devicerts.com/devices/enlight-adapter-cable-right-ace-00012-0",
        "model_reference": "ACE-00012-0",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Sensor Belt - Pair - Size P1",
        "url": "https://devicerts.com/devices/sensor-belt-pair-size-p1-ace-bfl0p1p0",
        "model_reference": "ACE-BFL0P1P0",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Enlight Belt - P0 - Left Ace-0001X-0",
        "url": "https://devicerts.com/devices/enlight-belt-p0-left-ace-0001x-0",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Enlight Belt - P0 - Right Ace-0001W-0",
        "url": "https://devicerts.com/devices/enlight-belt-p0-right-ace-0001w-0",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Enlight Belt - P1 - Left Ace-0001Z-0",
        "url": "https://devicerts.com/devices/enlight-belt-p1-left-ace-0001z-0",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Enlight Belt - P1 - Right Ace-0001Y-0",
        "url": "https://devicerts.com/devices/enlight-belt-p1-right-ace-0001y-0",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Enlight Belt - P2 - Right Ace-00010-0",
        "url": "https://devicerts.com/devices/enlight-belt-p2-right-ace-00010-0",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Adhesive Belt Xs Ace-ADH0A0P0",
        "url": "https://devicerts.com/devices/adhesive-belt-xs-ace-adh0a0p0",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Adhesive Belt M Ace-ADH0A2P0",
        "url": "https://devicerts.com/devices/adhesive-belt-m-ace-adh0a2p0",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Adhesive Belt S Ace-ADH0A1P0",
        "url": "https://devicerts.com/devices/adhesive-belt-s-ace-adh0a1p0",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Adhesive Belt L Ace-ADH0A3P0",
        "url": "https://devicerts.com/devices/adhesive-belt-l-ace-adh0a3p0",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Adhesive Belt Xl Ace-ADH0A4P0",
        "url": "https://devicerts.com/devices/adhesive-belt-xl-ace-adh0a4p0",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Adhesive Belt P0 Ace-ADH0P0P0",
        "url": "https://devicerts.com/devices/adhesive-belt-p0-ace-adh0p0p0",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Adhesive Belt P1 Ace-ADH0P1P0",
        "url": "https://devicerts.com/devices/adhesive-belt-p1-ace-adh0p1p0",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Adhesive Belt P2 Ace-ADH0P2P0",
        "url": "https://devicerts.com/devices/adhesive-belt-p2-ace-adh0p2p0",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Adhesive Belt P4 Ace-ADH0P4P0",
        "url": "https://devicerts.com/devices/adhesive-belt-p4-ace-adh0p4p0",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Adhesive Belt P3 Ace-ADH0P3P0",
        "url": "https://devicerts.com/devices/adhesive-belt-p3-ace-adh0p3p0",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Adhesive Belt Xxs Ace-ADH0P5P0",
        "url": "https://devicerts.com/devices/adhesive-belt-xxs-ace-adh0p5p0",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Sensor Belt P3 Ace-BFH0P3P0",
        "url": "https://devicerts.com/devices/sensor-belt-p3-ace-bfh0p3p0",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Sensor Belt P4 Ace-BFH0P4P0",
        "url": "https://devicerts.com/devices/sensor-belt-p4-ace-bfh0p4p0",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Sensor Belt Xs Ace-BFH0A0P0",
        "url": "https://devicerts.com/devices/sensor-belt-xs-ace-bfh0a0p0",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Sensor Belt L Ace-BFH0A3P0",
        "url": "https://devicerts.com/devices/sensor-belt-l-ace-bfh0a3p0",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pulmomap Tpl-EH003-0",
        "url": "https://devicerts.com/devices/pulmomap-tpl-eh003-0",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "ENLIGHT Belt - Size P2 – Left",
        "url": "https://devicerts.com/devices/enlight-belt-size-p2-left-ace-00011-0",
        "model_reference": "ACE-00011-0",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Sensor Belt - Pair - Size XXS",
        "url": "https://devicerts.com/devices/sensor-belt-pair-size-xxs-ace-bfl0p5p0",
        "model_reference": "ACE-BFL0P5P0",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "ENLIGHT Disposable Belt - Size N2",
        "url": "https://devicerts.com/devices/enlight-disposable-belt-size-n2-ace-00004-0",
        "model_reference": "ACE-00004-0",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Sensor Belt - Size P2",
        "url": "https://devicerts.com/devices/sensor-belt-size-p2-ace-bfh0p2p0",
        "model_reference": "ACE-BFH0P2P0",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "PulmoMap",
        "url": "https://devicerts.com/devices/pulmomap-tpl-eh000-0",
        "model_reference": "TPL-EH000-0",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Sensor Belt - Size P1",
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        "name": "Sensor Belt - Size M",
        "url": "https://devicerts.com/devices/sensor-belt-size-m-ace-bfh0a2p0",
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        "name": "Sensor Belt - Size XL",
        "url": "https://devicerts.com/devices/sensor-belt-size-xl-ace-bfh0a4p0",
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      {
        "name": "Sensor Belt - Size S",
        "url": "https://devicerts.com/devices/sensor-belt-size-s-ace-bfh0a1p0",
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      {
        "name": "Sensor Belt - Size XXS",
        "url": "https://devicerts.com/devices/sensor-belt-size-xxs-ace-bfh0p5p0",
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  "certificates": [],
  "recalls": []
}