Saudi Arabia SFDA registration ME0000006508SFDAA00174
Bakri Postpartum Balloon
Saudi Arabia·MD·Cook Incorporated·Class IIaActiveProduct information
Balloons to provide temporary control of postpartum uterine bleeding
Product use
intended to provide temporary control or reduction of postpartum uterine bleeding when
conservative management is warranted.
Device classification
- Risk Class
- Class IIa
- Product Category
- MD
- Product Type
- MD
Registration information
- Registration ID
- ME0000006508SFDAA00174
- Authorization ID
- GHTF-2019-3550
- Status
- Active
- Expire Date
- May 20, 2023
Manufacturer
- Manufacturer Name
- Cook Incorporated
Model information
- Model ID(s)
- J-S0S-100500 J-SOSR-100500
Product accessories
[]
About this record
Access comprehensive regulatory information for Bakri Postpartum Balloon in the Saudi Arabia medical device market through Pure Global AI's free database. This Class IIa device is registered with Saudi Arabia SFDA under registration number ME0000006508SFDAA00174 and manufactured by Cook Incorporated.
This page provides complete registration details including product category (MD), manufacturer information, model details, and regulatory compliance data from the official Saudi Arabia SFDA medical device database. Pure Global AI offers free access to Saudi Arabia's complete medical device registry, helping global MedTech companies navigate SFDA regulations efficiently.
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