Saudi Arabia SFDA registration ME0000001481SFDAA00840
Enzygnost HBsAg Confirmatory Test
Saudi Arabia·Chemicals·Siemens Healthcare diagnostics products Gmbh·Annex II List AActiveProduct information
for the detection of Hepatitis B
Product use
Confirmatory test for the detection of Hepatitis B (surface) antigen in conjunction with
Enzygnost® HBsAg 5.0 in human serum or Enzygnost® HBsAg 6.0 in human serum and
plasma
Device classification
- Risk Class
- Annex II List A
- Product Category
- Chemicals
- Product Type
- IVD
Registration information
- Registration ID
- ME0000001481SFDAA00840
- Authorization ID
- GHTF-2016-2406
- Status
- Active
- Expire Date
- May 29, 2017
Manufacturer
- Manufacturer Name
- Siemens Healthcare diagnostics products Gmbh
Model information
- Model ID(s)
- OSFC13
Product accessories
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About this record
Access comprehensive regulatory information for Enzygnost HBsAg Confirmatory Test in the Saudi Arabia medical device market through Pure Global AI's free database. This Annex II List A device is registered with Saudi Arabia SFDA under registration number ME0000001481SFDAA00840 and manufactured by Siemens Healthcare diagnostics products 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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