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
A L A T K E S E H A T A N
KEMENKES RI AKL 21002713681
Nama Dagang / Merek : NOUVAG High TorQ Kelompok / Kelas Resiko : Elektromedik Non Radiasi / B Kategori Produk : Peralatan Neurologi
Sub Kategori : Peralatan Neurologi Bedah
Jenis Produk : Powered simple cranial drills, burrs, trephines, and their accessories.
Tipe / Ukuran : High TorQ
Kemasan : Unit
Nama Produsen / Pabrikan : NOUVAG AG., Switzerland
Nama Pendaftar : PT. HOSPI NIAGA UTAMA, Jawa Barat Atas dasar lisensi dari : -
Ketentuan
1. Persetujuan izin edar berlaku sampai dengan 31 Desember 2022.
2. Wajib menyampaikan laporan berkala dan laporan jika ada kejadian yang tidak diinginkan akibat penggunaan Alat Kesehatan tersebut di atas sesuai ketentuan berlaku.
3. Izin edar ini merupakan persetujuan perpanjangan dari Nomor Izin Edar Alat Kesehatan KEMENKES RI AKL 21002713681 tanggal 22 Mei 2018. Dengan demikian izin edar sebelumnya dinyatakan tidak berlaku.
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, 22 November 2019
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
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.
LAMPIRAN
NOMOR IZIN EDAR
ALAT KESEHATAN KEMENKES RI AKL 21002713681
No. Deskripsi Tipe / Kode
1 Aksesoris 3705
2 Universal drill unit without Power-Pack 3706
3 Drill & Reamer unit without Power-Pack 3751
4 Oscillating saw unit without Power-Pack 3707
5 Padsaw 3708
6 Sternum saw unit without Power-Pack 3709
7 Power-Pack, non-sterilizable 3710
8 Battery charger with 1 charging bay 3711
9 Battery charger with 2 charging bays 3752
10 Battery charger with 4 charging bays 3712
11 Spickwirefeed 3713
12 Spickwirefeed 3714
13 Extension for spickwirefeed 3715
14 Adaptor for radiolucent angular gear 3716
15 Adaptor Aesculap connection DIN 3717
16 AO Essay small 3718
17 AO essay large 3719
18 1/4-essay 3720
19 Hudson-Essay 3721
20 Harris-Essay 3722
21 Hexagon Essay 3723
22 Jacobs drill chuck for 3724
23 3701 3725
24 Jacobs-drill chuck for 22279
25 3700 22283
26 Röhm-Drill Essay 22282
27 Quick-release chuck with latching 22284
28 Quick-release chuck without latching 3726
29 Albrecht-quick-release chuck 3727
30 Maintenance stand 3728
31 Sterilize-able sterile funnel 3729
32 Equipment cable EU standard 3730
33 Equipment cable UK standard 3731
34 Equipment cable US standard 3740
35 Equipment cable AU standard 3732
36 POA cable 3733
37 Spray oil sterilizable 3734
38 sterile packed saw blades for single use, L= 31,00 mm / T = 1,00 mm, package of 1 pcs.
KM97
Lampiran 1 dari 3 Halaman
No. Deskripsi Tipe / Kode 39 sterile packed saw blades for single use, L= 90,00 mm / W =
13,00mm / T = 1,00 mm, package of 10 pcs
KMS1310.58R
40 sterile packed saw blades for single use, L= 90,00 mm / W = 13,00mm / T = 1,19 mm, package of 10 pcs
KMS1312.59J
41 sterile packed saw blades for single use, L= 90,00 mm / W = 13,00mm / T = 1,27 mm, package of 10 pcs
KMS1313.57S
42 sterile packed saw blades for single use, L= 100,00 mm / W = 17,00mm / T = 1,27 mm, package of 10 pcs
KMS1713.L50
43 sterile packed saw blades for single use, L= 90,00 mm / W = 19,05mm / T = 1,27 mm, package of 10 pcs.
KMS1913.51S
44 sterile packed saw blades for single use, L= 90,00 mm / W = 19,05mm / T = 1,37 mm, package of 10 pcs.
KMS1914.51T
45 sterile packed saw blades for single use, L= 100,00 mm / W = 19,05mm / T = 1,19 mm, package of 10 pcs.
KMS1912.L50
46 sterile packed saw blades for single use, L= 90,00 mm / W = 22,00mm / T = 1,00 mm, package of 10 pcs.
KMS2210.56F
47 sterile packed saw blades for single use, L= 90,00 mm / W = 22,00mm / T = 1,27 mm, package of 10 pcs.
KMS2213.57F
48 sterile packed saw blades for single use, L= 70,00 mm / W = 19,05mm / T = 1,00 mm, package of 10 pcs.
KMS0001.SY
49 sterile packed saw blades for single use, L= 70,00 mm / W = 13,00mm / T = 1,19 mm, package of 10 pcs.
KMS1312.S50
50 sterile packed saw blades for single use, L= 90,00 mm / W = 25,40mm / T = 1,00 mm, package of 10 pcs.
KMS2510.56B
51 sterile packed saw blades for single use, L= 90,00 mm / W = 25,40mm / T = 1,19 mm, package of 10 pcs.
KMS2512.55J
52 sterile packed saw blades for single use, L= 90,00 mm / W = 25,40mm / T = 1,27 mm, package of 10 pcs.
KMS2513.55S
53 sterile packed saw blades for single use, L= 90,00 mm / W = 25,40mm / T = 1,37 mm, package of 10 pcs.
KMS2514.55T
54 sterile packed saw blades for single use, L= 68,00 mm / W = 27,00mm / T = 0,60 mm, package of 5 pcs.
KM519.017
55 sterile packed saw blades for single use, L= 68,00 mm / W = 19,50mm / T = 0,60 mm, package of 5 pcs.
KM519.012
56 sterile packed saw blades for single use, L= 90,00 mm / W = 13,00mm / T = 1,00 mm, package of 1 pcs.
EZ1310.M50
57 sterile packed saw blades for single use, L= 90,00 mm / W = 13,00mm / T = 1,19 mm, package of 1 pcs.
EZ1312.M50
58 sterile packed saw blades for single use, L= 90,00 mm / W = 13,00mm / T = 1,27 mm, package of 1 pcs.
EZ1313.M50
59 sterile packed saw blades for single use, L= 90,00 mm / W = 13,00mm / T = 1,37 mm, package of 1 pcs.
EZ1314.M50
60 sterile packed saw blades for single use, L= 90,00 mm / W = 19,05mm / T = 1,19 mm, package of 1 pcs.
EZ1912.M50
61 sterile packed saw blades for single use, L= 90,00 mm / W = 19,05mm / T = 1,27 mm, package of 1 pcs.
EZ1913.M50
62 sterile packed saw blades for single use, L= 90,00 mm / W = 19,05mm / T = 1,37 mm, package of 1 pcs.
EZ1914.M50
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
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.
No. Deskripsi Tipe / Kode
63 sterile packed saw blades for single use, L= 90,00 mm / W = 22,00mm / T = 1,00 mm, package of 1 pcs.
EZ2210.M50
64 sterile packed saw blades for single use, L= 90,00 mm / W = 22,00mm / T = 1,19 mm, package of 1 pcs.
EZ2212.M50
65 sterile packed saw blades for single use, L= 90,00 mm / W = 22,00mm / T = 1,27 mm, package of 1 pcs.
EZ2213.M50
66 sterile packed saw blades for single use, L= 90,00 mm / W = 22,00mm / T = 1,37 mm, package of 1 pcs
EZ2214.M50
67 sterile packed saw blades for single use, L= 90,00 mm / W = 22,00mm / T = 1,47 mm, package of 1 pcs
EZ2215.M50
68 sterile packed saw blades for single use, L= 67,90 mm / T = 1,00 mm, package of 1 pcs
KM 325R
69 sterile packed saw blades for single use, L= 60,00 mm / T = 1,10 mm, package of 1 pcs
KM 250R
Dengan ketentuan bahwa izin edar tersebut hanya berlaku untuk deskripsi dan tipe / kode produk yang tercantum dalam lampiran ini
Lampiran 3 dari 3 Halaman Jakarta, 22 November 2019
