Saudi Arabia SFDA registration ME0000000652SFDAA00024
REFLOTRON AMYLASE
Saudi Arabia·Chemicals·Roche Diagnostics GmbH·General IVD(Others)ActiveProduct information
Amylase quantitative determination
Product use
Test for the quantitative determination of the total activity of α‑amylase (EC 3.2.1.1) in blood, serum or
plasma with Reflotron systems.
Device classification
- Risk Class
- General IVD(Others)
- Product Category
- Chemicals
- Product Type
- IVD
Registration information
- Registration ID
- ME0000000652SFDAA00024
- Authorization ID
- GHTF-2017-0383
- Status
- Active
- Expire Date
- May 15, 2023
Manufacturer
- Manufacturer Name
- Roche Diagnostics GmbH
Model information
- Model ID(s)
- 11200658202
Product accessories
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About this record
Access comprehensive regulatory information for REFLOTRON AMYLASE in the Saudi Arabia medical device market through Pure Global AI's free database. This General IVD(Others) device is registered with Saudi Arabia SFDA under registration number ME0000000652SFDAA00024 and manufactured by Roche Diagnostics GmbH.
This page provides complete registration details including product category (Chemicals), 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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