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    Kementerian Kesehatan Republik Indonesia: Direktorat Jenderal Kefarmasian Dan Alat Kesehatan

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    Rizky Amelia Kusuma
    This document provides approval for the distribution of medical devices in Indonesia. Specifically, it grants license number KEMENKES RI AKD 10903021271 to PT. Sejahtera Karya Mulia to distribute TENOSA Latex Examination Gloves Powder Free, manufactured by PT. Haloni Jane, until March 2025. The gloves are classified as non-sterile, non-electromedical category A devices intended for general and individual hospital use. The license is subject to conditions such as submitting periodic reports and ensuring distribution only through authorized medical device distributors.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    Kementerian Kesehatan Republik Indonesia: Direktorat Jenderal Kefarmasian Dan Alat Kesehatan

    Uploaded by

    Rizky Amelia Kusuma
    14 views2 pages
    This document provides approval for the distribution of medical devices in Indonesia. Specifically, it grants license number KEMENKES RI AKD 10903021271 to PT. Sejahtera Karya Mulia to distribute TENOSA Latex Examination Gloves Powder Free, manufactured by PT. Haloni Jane, until March 2025. The gloves are classified as non-sterile, non-electromedical category A devices intended for general and individual hospital use. The license is subject to conditions such as submitting periodic reports and ensuring distribution only through authorized medical device distributors.

    Original Description:

    JGJH

    Original Title

    S-M19820009240620

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    This document provides approval for the distribution of medical devices in Indonesia. Specifically, it grants license number KEMENKES RI AKD 10903021271 to PT. Sejahtera Karya Mulia to distribute TENOSA Latex Examination Gloves Powder Free, manufactured by PT. Haloni Jane, until March 2025. The gloves are classified as non-sterile, non-electromedical category A devices intended for general and individual hospital use. The license is subject to conditions such as submitting periodic reports and ensuring distribution only through authorized medical device distributors.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    14 views2 pages

    Kementerian Kesehatan Republik Indonesia: Direktorat Jenderal Kefarmasian Dan Alat Kesehatan

    Uploaded by

    Rizky Amelia Kusuma
    This document provides approval for the distribution of medical devices in Indonesia. Specifically, it grants license number KEMENKES RI AKD 10903021271 to PT. Sejahtera Karya Mulia to distribute TENOSA Latex Examination Gloves Powder Free, manufactured by PT. Haloni Jane, until March 2025. The gloves are classified as non-sterile, non-electromedical category A devices intended for general and individual hospital use. The license is subject to conditions such as submitting periodic reports and ensuring distribution only through authorized medical device distributors.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

    KEMENTERIAN KESEHATAN REPUBLIK INDONESIA

    DIREKTORAT JENDERAL KEFARMASIAN DAN ALAT KESEHATAN


    Jalan H.R. Rasuna Said Blok X-5 Kavling 4 - 9 Jakarta 12950
    Telepon : (021) 5201590 Pesawat 2029, 8011
    Faksimile : (021) 52964838 Kotak Pos : 203

    Berdasarkan Peraturan Menteri Kesehatan R.I Nomor 62 Tahun 2017 Tentang Izin Edar Alat Kesehatan,
    Alat Kesehatan Diagnostik In Vitro Dan Perbekalan Kesehatan Rumah Tangga dengan ini diberikan
    persetujuan untuk diedarkan dengan :

    NOMOR IZIN EDAR

    ALAT KESEHATAN

    KEMENKES RI AKD 10903021271

    Nama Dagang / Merek : TENOSA Latex Examination Gloves Powder Free


    Kelompok / Kelas Resiko : Non Elektromedik Non Steril / A

    Kategori Produk : Peralatan Rumah Sakit Umum dan Perorangan

    Sub Kategori : Peralatan Rumah Sakit Umum dan Perorangan Lainnya

    Jenis Produk : Patient examination glove.

    Tipe / Ukuran : XS, S, M, L, XL

    Kemasan : Box

    Nama Produsen / Pabrikan : PT. HALONI JANE, Banten

    Nama Pendaftar : PT. SEJAHTERA KARYA MULIA, DKI Jakarta

    Atas dasar lisensi dari : -

    Ketentuan
    1. Persetujuan izin edar berlaku sampai dengan 16 Maret 2025.
    2. Wajib menyampaikan laporan berkala dan laporan jika ada kejadian yang tidak diinginkan akibat
    penggunaan Alat Kesehatan tersebut di atas sesuai ketentuan berlaku.
    3. Produsen hanya boleh menyalurkan produknya melalui Penyalur Alat Kesehatan (PAK).
    4. Apabila dikemudian hari ada pihak lain yang berhak atas merek dan/atau keagenan produk
    tersebut, pendaftar bersedia mengembalikan izin edar.
    5. Penandaan dan informasi produk yang terlampir merupakan bagian yang tidak terpisahkan dari
    persetujuan izin edar ini.
    6. Apabila di kemudian hari terdapat kekeliruan, maka persetujuan izin edar ini akan ditinjau
    kembali.

    Jakarta, 16 Juli 2020

    Catatan:
    - UU ITE No 11 Tahun 2007 Pasal 5 ayat 1
    Informasi Elektronik dan/atau Dokumen Elektronik dan/atau hasil cetaknya merupakan alat bukti hukum yang sah.
    - Dokumen ini telah ditandatangani secara elektronik menggunakan sertifikat elektronik yang diterbitkan BSrE.

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