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Indonesia Registration Certificate TD

Indonesia Registration Certificate TD
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Indonesia Registration Certificate TD

Product catalog summary
Business Licensing Overview:
The Government of the Republic of Indonesia has issued a Business Licensing for Supporting Business Activities (PB-UMKU) for the importation of medical devices. This license is granted to PT Qualtek Konsultan Jakarta, a foreign investment company (PMA) located in Tangerang, Banten. The business classification code is 46691, which pertains to the wholesale trade of laboratory, pharmaceutical, and medical equipment for humans.
Administrative Requirements:
The license includes administrative requirements that must be adhered to, and the business activities must comply with applicable laws and regulations. The document is electronically signed and stored in the OSS system, with corrections made if necessary.
Technical Data and Product Information:
The license covers the importation of NuCraft Tissue Adhesive, a non-electromedical sterile product classified under general and plastic surgery equipment. The product is manufactured by Neo Modulus (Shandong) Medical Sci-Tech Co., Ltd., China. The license is valid until March 20, 2029, with obligations for periodic reporting and incident reporting.
Product Specifications:
The tissue adhesive is available in various ampoule sizes ranging from 0.3g to 3.0g, each with a specific type/code. The license is valid only for the specified descriptions and types/codes listed in the annex.
Packaging and Labelling:
The product packaging includes tertiary (box), secondary (blister box), and primary (glass ampoule) packaging. Labels are attached to each packaging level, with distributor information provided by PT Qualtek Konsultan Jakarta.
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Catalog excerpts

Indonesia Registration Certificate TD-1

PEMERINTAH REPUBLIK INDONESIA PERIZINAN BERUSAHA UNTUK MENUNJANG KEGIATAN USAHA IZIN EDAR ALAT KESEHATAN IMPOR PB-UMKU: 812000191057200040003 Pemerintah Republik Indonesia menerbitkan Perizinan Berusaha Untuk Menunjang Kegiatan Usaha (PB-UMKU), yang merupakan Izin edar alat kesehatan impor kepada Pelaku Usaha berikut ini: 1. Nama Pelaku Usaha 2. Nomor Induk Berusaha (NIB) 3. Alamat Kantor 4. Status Penanaman Modal 5. Kode Klasifikasi Baku Lapangan Indonesia (KBLI) 6. Lokasi Usaha : PT QUALTEK KONSULTAN JAKARTA : 8120001910572 : Ruko Icon Business Park Blok K No 06, BSD City, Desa/Kelurahan Sampora, Kec. Cisauk, Kab. Tangerang, Provinsi Banten Kode Pos: 15345 : Penanaman Modal Asing (PMA) Usaha : 46691 - Perdagangan Besar Alat Laboratorium, Alat Farmasi Dan Alat Kedokteran Untuk Manusia : Jalan Raya Cisauk Desa/Kelurahan Sampora, Kec. Cisauk, Kab. Tangerang, Provinsi Banten Kode Pos: 15345 Telah Memenuhi Persyaratan: 1. Persyaratan Administrasi Lampiran Perizinan Berusaha Untuk Menunjang Kegiatan Usaha ini memuat data teknis yang merupakan bagian tidak terpisahkan dari dokumen ini. Pelaku Usaha tersebut di atas wajib menjalankan kegiatan usahanya sesuai dengan ketentuan perundang-undangan yang berlaku. Diterbitkan tanggal: 24 Juni 2024 a.n. Menteri Kesehatan Menteri Investasi/ Kepala Badan Koordinasi Penanaman Modal, Ditandatangani secara elektronik Dicetak tanggal: 24 Juni 2024 Powered by TCPDF (www.tcpdf.org) Dokumen ini diterbitkan sistem OSS berdasarkan data dari Pelaku Usaha, tersimpan dalam sistem OSS, yang menjadi tanggung jawab Pelaku Usaha. Dalam hal terjadi kekeliruan isi dokumen ini akan dilakukan perbaikan sebagaimana mestinya. Dokumen ini telah ditandatangani secara elektronik menggunakan sertifikat elektronik yang diterbitkan oleh BSrE-BSSN. Data lengkap Perizinan Berusaha dapat diperoleh melalui sistem OSS menggunakan hak akses.

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Indonesia Registration Certificate TD-2

PEMERINTAH REPUBLIK INDONESIA PERIZINAN BERUSAHA UNTUK MENUNJANG KEGIATAN USAHA LAMPIRAN IZIN EDAR ALAT KESEHATAN IMPOR PB-UMKU : 812000191057200040003 Lampiran berikut memuat data teknis Izin Edar Alat Kesehatan Impor, sebagai berikut: KEMENKES RI AKL 21603421335 Nama Dagang / Merek : NuCraft Tissue Adhesive Kelompok / Kelas Resiko : Non Elektromedik Steril / C Kategori Produk : Peralatan Bedah Umum dan Bedah Plastik Sub Kategori : Peralatan Bedah Jenis Produk : Tissue adhesive for the topical approximation of skin Tipe / Ukuran : Terlampir Kemasan : Box isi 1 tissue adhesive dan 1 Pasteur pipette...

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Indonesia Registration Certificate TD-3

PEMERINTAH REPUBLIK INDONESIA PERIZINAN BERUSAHA UNTUK MENUNJANG KEGIATAN USAHA LAMPIRAN IZIN EDAR ALAT KESEHATAN IMPOR PB-UMKU : 812000191057200040003 KEMENKES RI AKL 21603421335 Tipe / Kode Tissue Adhesive (0.3 g/Ampoule) Tissue Adhesive (0.4 g/Ampoule) Tissue Adhesive (0.5 g/Ampoule) Tissue Adhesive (0.6 g/Ampoule) Tissue Adhesive (0.7 g/Ampoule) Tissue Adhesive (0.8 g/Ampoule) Tissue Adhesive (0.9 g/Ampoule) Tissue Adhesive (1.0 g/Ampoule) Tissue Adhesive (1.2 g/Ampoule) Tissue Adhesive (1.5 g/Ampoule) Tissue Adhesive (1.8 g/Ampoule) Tissue Adhesive (2.0 g/Ampoule) Tissue Adhesive (2.5 g/Ampoule)...

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Indonesia Registration Certificate TD-4

Labelling and Packaging Tissue Adhesive Box Packaging (Tertiary packaging) Distributor’s Label The following are the labels attached to the box packaging (red box):

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Indonesia Registration Certificate TD-5

Distributor’s label: Distributed By: PT. Qualtek Konsultan Jakarta Tangerang, Indonesia Marketing License Number KEMENKES RI AKL…….. Blister Box (secondary packaging) Glass Ampoule (Primary Packaging) The following are the label stickers pasted to the Tissue Adhesive and Pasteur pipette respectively. Fields indicated with orange box will vary across mode. Powered by TCPDF (www.tcpdf.o

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.