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Enzygnost Anti-HBc/IgM - SFDA Registration ME0000001481SFDAA00846

Access comprehensive regulatory information for Enzygnost Anti-HBc/IgM 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 ME0000001481SFDAA00846 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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SFDA Official Data
Annex II List A
ME0000001481SFDAA00846
Enzygnost Anti-HBc/IgM
SFDA Registration: ME0000001481SFDAA00846
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Product Information

for the qualitative detection of IgM antibodies to hepatitis B

Product Use

Enzyme immunoassay for the qualitative detection of IgM antibodies to hepatitis B (core) antigen in serum or plasma. The enzyme immunoassay is processed on the BEPยฎ II, BEPยฎ III and BEPยฎ 2000 ELISA processors. The test was developed for investigation of individual samples, not pooled samples. The product is for inโ€‘vitro diagnostic use only.

Device Classification
Risk Class
Annex II List A
Product Category
Chemicals
Product Type
IVD
Registration Information
Registration ID
ME0000001481SFDAA00846
Authorization ID
GHTF-2016-2406
Status
Active
Expire Date
May 29, 2017
Model Information
Model ID(s)
OWSE13
Product Accessories

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