{
  "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": {
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        "Wireless Bluetooth Hearing Aid DCM-220, PB-A01, PB-A02, PB-A03, PB-A04, PB-A05"
      ],
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        "Export Device to the United States But Perform No Other Operation on Device",
        "Manufacture Medical Device for Another Party (Contract Manufacturer)",
        "Manufacture Medical Device"
      ],
      "registration": {
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        "fei_number": "3016171795",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "GUANGDONG ENNO MEDICAL TECHNOLOGY CO., LTD.",
        "address_line_1": "No. 406, 4th Floor, Workshop G, No. 8 Hua 'an Road, Zhongkai High-Tech Zone,",
        "address_line_2": "",
        "city": "Huizhou Guangdong",
        "state_code": "",
        "iso_country_code": "CN",
        "zip_code": "",
        "postal_code": "516006",
        "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": "Guangdong ENNO Medical Technology Co., Ltd.",
          "owner_operator_number": "10091567",
          "official_correspondent": {
            "first_name": "Tammy.",
            "middle_initial": "",
            "last_name": "Tan",
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            "phone_number": "86-195-3287-5429"
          },
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            "address_1": "No. 406, 4th Floor, Workshop G, No. 8 Hua 'an Road, Zhongkai High-Tech Zone,",
            "address_2": "",
            "city": "Huizhou",
            "state_code": "CN-GD",
            "state_province": "Guangdong",
            "iso_country_code": "CN",
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      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "OSM",
          "created_date": "2024-10-16",
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          "openfda": {
            "device_name": "Hearing Aid, Air-Conduction With Wireless Technology, Prescription",
            "medical_specialty_description": "Ear, Nose, Throat",
            "regulation_number": "874.3305",
            "device_class": "2"
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}