PIHAK BERKUASA PERANTI PERUBATAN

MEDICAL DEVICE AUTHORITY

AKTA PERANTI PERUBATAN 2012 (AKTA 737)
MEDICAL DEVICE ACT 2012 (ACT 737)
SIJIL PENDAFTARAN PERANTI PERUBATAN
MEDICAL DEVICE REGISTRATION CERTIFICATE
Seksyen 5(1) Akta 737
Section 5(1) of Act 737

No. Pendaftaran: GB5509421-65704 Tarikh Sah Pendaftaran: 04/07/2021 - 03/07/2026

Registration No.: Registration Validity Date:

Sijil ini adalah dengan ini diberi kepada: AIM MEDICAL SUPPLIES SDN. BHD.
This certificate is hereby issued to:

UNIT 28-G (GROUND FLOOR), BLOCK C,

yang beralamat di: ZENITH CORPORATE PARK, NO. 1, JALAN
which is located at: SS7/26, KELANA JAYA,
47301
PETALING JAYA SELANGOR DARUL EHSAN

bagi mengesahkan peranti perubatan seperti yang dinyatakan dalam Lampiran 1 adalah berdaftar di
bawah Seksyen 5(1) Akta 737.
to confirm that the medical device as detailed out in Attachment 1 is registered under Section 5(1) of Act
737.

Pendaftaran ini diberikan tertakluk kepada peruntukan-peruntukan di bawah Akta 737 dan peraturan-
peraturan yang dibuat dibawahnya serta syarat-syarat seperti di Lampiran 2.
This registration is granted subject to the provisions under Act 737 and its subsidiary legislations and the
conditions as in Attachment 2.

AHMAD SHARIFF BIN HAMBALI

KETUA EKSEKUTIF
CHIEF EXECUTIVE
PIHAK BERKUASA PERANTI PERUBATAN
MEDICAL DEVICE AUTHORITY
LAMPIRAN 1
Attachment 1

No. Pendaftaran: GB5509421-65704

Registration No.:
Butir-butir peranti perubatan yang didaftarkan
Particulars of the registered medical device
Nama Peranti Perubatan LELTEK ULTRASOUND IMAGING SYSTEM
Medical Device Name
Kelas CLASS B Jenama LELTEK
Class Brand
Kelompok FAMILY
Group
Nama dan alamat LELTEK INC.
pembuat: 6F-3., NO.293, SEC.1, BEIXIN RD., XINDIAN DIST., NEW TAIPEI CITY,
Name and address of 23147
manufacturer TAIWAN

APPENDIX

BRIEF DESCRIPTION OF
NO NAME AS PER DEVICE LABEL IDENTIFIER
ITEM

Leltek LeSono LU700L Wireless

1 Leltek LU700L 04719882150067
5 - 10 MHz Linear probe

Leltek LeSono LU700C Wireless

2 Leltek LU700C 04719882150050
2 - 5 MHz Convex probe

Leltek LeSono LU710C

3 Leltek LU710C 04719882150036 Transducer Convex 3.2MHz
probe

Leltek LeSono LU710M

4 Leltek LU710M 04719882150074 Transducer M8-4 Micro Convex
probe

Leltek LeSono LU710PA

5 Leltek LU710PA 04719882150081 Transducer P4-2 Phased Array
probe

"End Of Product List"

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