`

Operations Sector ‫ﻗﻄﺎ ع اﻟﻌﻤﻠﻴﺎت‬

Executive Department of ‫اﻹدارة اﻟﺘـﻨﻔﻴﺬﻳـــﺔ‬

registration and licensing ‫ﻟﻠﺘﺴــﺠﻴﻞ واﻟﺘـﺮاﺧﻴـﺺ‬

‫رﺧﺼﺔ ﻣﻤﺜﻞ ﻗﺎﻧﻮﻧﻲ‬

Authorised Representative License

Issuing Authority: Saudi Food And drug Authority. ‫ اﻟﻬﻴﺌ ﺔ اﻟﻌﺎﻣ ﺔ ﻟﻠﻐﺬاء واﻟﺪواء‬:‫ﺟﻬﺔ اﻻﺻﺪار‬
Enabling Legislation: Medical Device Interim ‫ ﻻﺋﺤﺔ رﻗﺎﺑﺔ اﻷﺟﻬﺰة واﻟﻤﻨﺘﺠﺎت‬:‫اﻟﻤﺮﺟﻊ اﻟﻘﺎﻧﻮﻧﻲ‬
Regulation supported by Implementing Rule
MDS-IR5 on Licensing of Authorised
‫( اﻟﺨﺎﺻﺔ ﺑﺘﺮﺧﻴﺺ‬IR5-MDS) ‫اﻟﻄﺒﻴﺔ واﻟ ﻘﻮاﻋﺪ ا ﺟﺮاﺋﻴﺔ‬
Representatives. .‫اﻟﻤﻤﺜﻞ اﻟ ﻘﺎﻧﻮﻧﻲ‬

Licensed Activity: acting on behalf of the ‫ اﻟﺘﻤﺜﻴﻞ اﻟ ﻘﺎﻧﻮﻧﻲ ﻟﻠﻤﺼﻨﻊ داﺧﻞ‬:‫ﻧﺸﺎط اﻟﻤﻨﺸﺄة‬
MANUFACTURER for the medical device within the ‫اﻟﻤﻤﻠﻜ ﺔ اﻟﻌﺮﺑﻴ ﺔ اﻟﺴﻌﻮدﻳ ﺔ وﻓﻖ§ ﻻﺗ ﻔﺎﻗﻴ ﺔ اﻟﺘﻤﺜﻴﻞ‬
KSA according to the AR agreement with the
‫اﻟ ﻘﺎﻧﻮﻧﻲ ﻓﻴﻤﺎ ﻋﺪا اﻟﻤﺎدة اﻟﺨﺎﺻ ﺔ ﺑﺎﻟﻤﻬﺎ م واﻷﺣﻜﺎ م‬
exception to the paragraph pertaining additional
tasks and Provisions. .‫اﻻﺿﺎﻓﻴ ﺔ اﻻﺧﺘﻴﺎرﻳ ﺔ‬
‫ﺷﺮﻛﺔ اﻟﻨﻘﺎء اﻟﻤﻤﻴﺰ اﻟﺘﺠﺎرﻳﺔ‬ ‫أﺻﺪرت رﺧﺼﺔ ﻣﻤﺜﻞ ﻗﺎﻧﻮﻧﻲ ﻟـ‬

An Authorised Representative license has been issued to: PURE PLUS LLC

License Number: ARL-2021-MD-1256 :‫رﻗﻢ اﻟﺮﺧﺼﺔ ﺑﺎﻟﻨﻈﺎ م‬

NINGBO HAISHU ESCO MEDICAL TECHNOLOGY CO.,

MANUFAC TURER: :‫اﻟُﻤﺼـﻨﻊ‬
LTD.
Account number for AR: C-9060 :‫رﻗﻢ اﻟﺤﺴﺎب ﻟﻠﻤﻤﺜﻞ اﻟﻘﺎﻧﻮﻧﻲ‬

Issuing date/ Expir y date: 07/7/2021 - 06/7/2022 :‫ ﺗﺎرﻳﺦ اﻻﻧﺘﻬﺎء‬/ ‫ﺗﺎرﻳﺦ اﻻﺻﺪار‬

Issuance Type: New ‫ﺟﺪﻳﺪ‬ :‫ﻧﻮع اﻻﺻﺪار‬

Device categor y(ies): :‫أﺻﻨﺎف اﻷﺟﻬﺰة واﻟﻤﻨﺘﺠﺎت اﻟﻄﺒﻴﺔ‬

1. Dental Devices

Establishments Licensing Department Manager ‫ﻣﺪﻳﺮ إدارة ﺗﺮﺧﻴﺺ اﻟﻤﻨﺸﺂت‬

‫ ﺑﺪر ﺑﻦ ﻓﻬﺪ اﻟﻌﻘﻴﻞ‬.‫أ‬

Page 1 of 1