{
  "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": "2026-09-07",
    "results": {
      "skip": 0,
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      "proprietary_name": [
        "Dental Extraoral Suction unit",
        "Infinity Endo File Removal Kit"
      ],
      "establishment_type": [
        "Manufacture Medical Device for Another Party (Contract Manufacturer)",
        "Export Device to the United States But Perform No Other Operation on Device",
        "Manufacture Medical Device"
      ],
      "registration": {
        "registration_number": "3015136927",
        "fei_number": "3015136927",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "SHENZHEN ROGIN MEDICAL CO., LTD",
        "address_line_1": "Rm 3109, Bldg 6, Tian'an Cloud Park, Bantian Str, Longgang Dist",
        "address_line_2": "",
        "city": "shenzhen Guangdong",
        "state_code": "",
        "iso_country_code": "CN",
        "zip_code": "",
        "postal_code": "518129",
        "us_agent": {
          "name": "Leeyeo Kee",
          "business_name": "Regrek LLC",
          "bus_phone_area_code": "302",
          "bus_phone_num": "6089028",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "regrek.cs@hotmail.com",
          "address_line_1": "19 Holly Cove Ln.,",
          "address_line_2": "",
          "city": "Dover",
          "state_code": "DE",
          "iso_country_code": "US",
          "zip_code": "19901",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "SHENZHEN ROGIN MEDICAL CO., LTD",
          "owner_operator_number": "10058732",
          "official_correspondent": {
            "first_name": "Xiaoran",
            "middle_initial": "",
            "last_name": "Xu",
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            "phone_number": "86-755-2675-8272"
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            "address_2": "",
            "city": "Shenzhen",
            "state_code": "CN-GD",
            "state_province": "Guangdong",
            "iso_country_code": "CN",
            "postal_code": "518129"
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      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "EBR",
          "created_date": "2020-05-01",
          "owner_operator_number": "10058732",
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          "openfda": {
            "device_name": "Unit, Suction Operatory",
            "medical_specialty_description": "Dental",
            "regulation_number": "872.6640",
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}