Executive Department of

‫ا ﻹ د ا ر ة ا ﻟ ﺘ ﻨ ﻔ ﻴ ﺬ ﻳ ﺔ ﻟ ﻠ ﺘ ﺴ ﺠ ﻴ ﻞ و ا ﻟ ﺘﺮ ا ﺧ ﻴ ﺺ‬
Registration And Licensing
‫ﻗ ﻄ ﺎ ع ا ﻟ ﻌ ﻤﻠ ﻴ ﺎ ت‬
Operation Sector

‫ ﻣ ﻨ ﺘ ﺞ ﻃ ﺒ ﻲ ﻣ ﻨ ﺨ ﻔ ﺾ ا ﻟ ﺨ ﻄ ﻮ ر ة‬/ ‫إﺷ ﻌ ﺎ ر ﺗ ﺴ ﺠ ﻴ ﻞ ﺟ ﻬ ﺎ ز‬
Notification of Low-Risk Medical Device Registration

Issuing Date: 30/12/2021 Registration Number: LR-202112-C-7514--SFDA-6495 :‫ر ﻗ ﻢ ا ﻟ ﺘ ﺴ ﺠ ﻴ ﻞ‬ 26/5/1443 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻹ ﺻ ﺪ ا ر‬

Expiry Date: 29/12/2024 Version Number: 1 :‫ر ﻗ ﻢ ا ﻹ ﺻ ﺪ ا ر‬ 28/6/1446 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻻ ﻧ ﺘ ﻬ ﺎ ء‬
Last Version Date: 30/12/2021 26/5/1443 :‫ﺗ ﺎ ر ﻳ ﺦ أ ﺧﺮ إ ﺻ ﺪ ا ر‬

This notification was issued under the Medical Devices and ‫أﺻﺪر ﻫﺬا اﻹﺷﻌﺎر ﺑﻤﻮﺟﺐ ﻻﺋﺤﺔ رﻗﺎﺑﺔ اﻷﺟﻬﺰة واﻟﻤﻨﺘﺠﺎت اﻟﻄﺒ ﻴﺔ‬
Products Interim Regulation and the Implementing rules for ‫واﻟﻘﻮاﻋﺪ اﻹﺟﺮاﺋ ﻴﺔ اﻟﺨﺎﺻﺔ ﺑﺘﺴﺠ ﻴﻞ اﻷﺟﻬﺰة واﻟﻤﻨﺘﺠﺎت اﻟﻄﺒ ﻴﺔ ﻣﻨﺨﻔﻀﺔ‬
the registration of low-risk medical devices products. ‫اﻟﺨﻄﻮرة‬

This Notification allows:

C-7514 :‫ﻫﺬا اﻹﺷﻌﺎر ﻳﺨﻮل‬

Ethraa Med
Al Imam Abdul Aziz,,234 4 2 Saudi Arabia

To market the medical devices listed in below table in the ‫ اﻟﻤﻨﺘﺠﺎت اﻟﻄﺒ ﻴﺔ اﻟﻤﺤﺪدة ﻓﻲ اﻟﺠﺪول أدﻧﺎه ﻓﻲ‬/ ‫ﺑﺘﺴﻮ ﻳﻖ اﻷﺟﻬﺰة‬
Kingdom of Saudi Arabia ‫اﻟﻤﻤﻠﻜﺔ اﻟﻌﺮﺑ ﻴﺔ اﻟﺴﻌﻮد ﻳﺔ‬

The scientific name of this device is Hydrafacial , is a facial

treatment using a patented device to deliver exfoliation,
Medical Device Description ‫ اﻟﻤﻨﺘﺞ‬/ ‫وﺻﻒ اﻟﺠﻬﺎز‬
cleansing, extraction, and hydration to the face. This system
uses a vortex swirling action to del...

Medical Device National ‫ اﻟﻤﻨﺘﺞ اﻟﻄﺒﻲ ﻓﻲ‬/ ‫رﻗﻢ ﻗ ﻴﺪ اﻟﺠﻬﺎز‬

ME0000005446SFDAA00003
Listing Number ‫اﻟﺴﺠﻞ اﻟﻮﻃﻨﻲ‬

Brand / Trade Name Synergy+ ‫اﻹﺳﻢ اﻟﺘﺠﺎري‬

Manufacturer Name Beijing Anchorfree Technology ‫أﺳﻢ اﻟﻤﺼﻨﻊ‬

Manufacturer Number ME0000005446 ‫رﻗﻢ اﻟﻤﺼﻨﻊ‬

NO.2, Kechuangdongwujie, Tongzhou District, Beijing,

Manufacturer Address ‫ﻋﻨﻮان اﻟﻤﺼﻨﻊ‬
China,Beijing,101111 China

The notification is considered invalid when updating the ‫و وﺻﻒ اﻟﺠﻬﺎز‬/‫ﻳﻌﺘﺒﺮ ﻫﺬا اﻹﺷﻌﺎر ﻻﻏﻲ ﻋﻨﺪ ﺗﺤﺪ ﻳﺚ ﺑ ﻴﺎﻧﺎت اﻟﻤﻨﺸﺄة أو‬
facility data or / and the description of the device and all ‫وﻛﻞ ﻣﺎ ﻳﻄﺮأ ﻣﻦ ﺗﻌﺪ ﻳﻼت ﺟﻮﻫﺮ ﻳﺔ‬
that is necessary or major information changes.

‫رﺋ ﻴﺲ ﻗﺴﻢ ﺗﺴﺠ ﻴﻞ اﻷﺟﻬﺰة اﻟﻄﺒ ﻴﺔ‬

Head Of Medical Devices Registration

‫ وﻟ ﻴﺪ ﺑﻦ ﻓﻬﺪ اﻟﺪوﺳﺮي‬.‫م‬
Eng. WALEED FAHAD ALDOSARI