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: 15/3/2021 Registration Number: LR-20213-C-2429--SFDA-1000 :‫ر ﻗ ﻢ ا ﻟ ﺘ ﺴ ﺠ ﻴ ﻞ‬ 02/8/1442 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻹ ﺻ ﺪ ا ر‬

Expiry Date: 14/3/2024 Version Number: 1 :‫ر ﻗ ﻢ ا ﻹ ﺻ ﺪ ا ر‬ 05/9/1445 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻻ ﻧ ﺘ ﻬ ﺎ ء‬
Last Version Date: 15/3/2021 02/8/1442 :‫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-24 29 :‫ﻫﺬا اﻹﺷﻌﺎر ﻳﺨﻮل‬

Home of Gulf Elite

Ibn Al Amid,,11322 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

SAM® Pelvic Sling is the first and only force-controlled

circumferential pelvic belt. Featuring an optimized one-piece
Medical Device Description ‫ اﻟﻤﻨﺘﺞ‬/ ‫وﺻﻒ اﻟﺠﻬﺎز‬
design, it’s scientifically proven to safely and effectively reduce
and stabilize open-book pelvic ri...

Medical Device National ‫ اﻟﻤﻨﺘﺞ اﻟﻄﺒﻲ ﻓﻲ‬/ ‫رﻗﻢ ﻗ ﻴﺪ اﻟﺠﻬﺎز‬

ME0000013556SFDAA00008
Listing Number ‫اﻟﺴﺠﻞ اﻟﻮﻃﻨﻲ‬

Brand / Trade Name SAM PELVIC SLING II ‫اﻹﺳﻢ اﻟﺘﺠﺎري‬

Manufacturer Name SAM Medical Products ‫أﺳﻢ اﻟﻤﺼﻨﻊ‬

Manufacturer Number ME0000013556 ‫رﻗﻢ اﻟﻤﺼﻨﻊ‬

Manufacturer Address 12200 SW Tualatin RD,Tualatin, Oregon,97062 United States ‫ﻋﻨﻮان اﻟﻤﺼﻨﻊ‬

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