{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-26",
    "results": {
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        "Rectal Balloon Probe (B08FR-4; B10FR-4; B12FR-4)",
        "UROCOMMANDER Equipment for Urodynamics",
        "Urodynamics Catheter Extender (EXTUR10FR120)",
        "Silicone Tube for Infusion Mechanisms (DUCTUB001)",
        "Infusion Set for Urodynamics Infusion Pump (EQUIPOBP1)",
        "UROCOMMANDER Equipment for Flowmetry",
        "UROCOMMANDER Equipment for Biofeedback",
        "Double Lumen Pig Tail Probe (4.1860B; SDL-PG-6FR; SDL-PG-7FR; SDL-PG-8FR)",
        "Double Lumen Probe (DL6FR; DL6FR-2F; DL6FR-30; DL7FR; DLFR8)",
        "PVC Rectal Balloon Probe (SDBL10PVC42; SDBL12PVC42; SDBL10PVC124; SDBL12PVC124)",
        "UROCOMMANDER Equipment with EMG",
        "Biofeedback Balloon Probe (SB-BIO)",
        "BP-1 Urodynamics Infusion Pump - Peristaltic Pump",
        "Connector for Minimally Invasive Male Urodynamics (DUAUMI)",
        "UROCOMMANDER Equipment for Flowmetry Uroflow"
      ],
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        "fei_number": "3016854619",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "ALACER INDUSTRIA ELETRONICA LTDA",
        "address_line_1": "Rua Batista de Melo 113",
        "address_line_2": "Jardim Jabaquara",
        "city": "Sao Paulo",
        "state_code": "",
        "iso_country_code": "BR",
        "zip_code": "",
        "postal_code": "04383-080",
        "us_agent": {
          "name": "Lucas Rodrigues",
          "business_name": "PASSARINI CRO AND REGULATORY SOLUTIONS LLC",
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          "bus_phone_num": "8496760",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "usagent@passarini.com.br",
          "address_line_1": "10185 Henbury St",
          "address_line_2": "",
          "city": "Orlando",
          "state_code": "FL",
          "iso_country_code": "US",
          "zip_code": "32832",
          "postal_code": ""
        },
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          "firm_name": "ALACER INDUSTRIA ELETRONICA LTDA",
          "owner_operator_number": "10086657",
          "official_correspondent": {
            "first_name": "Iracele",
            "middle_initial": "",
            "last_name": "Alkimim  Sanches",
            "subaccount_company_name": "",
            "phone_number": "55-11-56716790-x"
          },
          "contact_address": {
            "address_1": "Rua Batista de Melo 113",
            "address_2": "Jardim Jabaquara",
            "city": "Sao Paulo",
            "state_code": "BR-SP",
            "state_province": "",
            "iso_country_code": "BR",
            "postal_code": "04383-080"
          }
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      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "FEN",
          "created_date": "2024-01-12",
          "owner_operator_number": "10086657",
          "exempt": "",
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            "device_name": "Device, Cystometric, Hydraulic",
            "medical_specialty_description": "Gastroenterology, Urology",
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}