Manufacturer

Seramun

GermanyLegal entities : Seramun Diagnostica GmbH

Markets : Germany

Approvals : EU – class A, B

23 categories, 36 models including 36 on the market, 1 country

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
H. pylori antibody assays	W0105010402	Seraline® Anti-Helicobacter-6 IgA98/79 Seraline® Anti-Helicobacter-6 IgG98/79 SeraSpot® Anti-Helicobacter-6 IgA2 refs98/79 SeraSpot® Anti-Helicobacter-6 IgG2 refs98/79	– 98/79	EUDAMED record Report an error
Yersinia	W0105011706	Seraline® Anti-Yersinia-6 IgA2 refs98/79 Seraline® Anti-Yersinia-6 IgG2 refs98/79 SeraSpot® Anti-Yersinia-6 IgA2 refs98/79 SeraSpot® Anti-Yersinia-6 IgG2 refs98/79	– 98/79	EUDAMED record Report an error
IVD instruments - other	W0299	Seramun SpotSight® plate mono2 refs Seramun SpotSight® scan Seramun SpotSight® well	A IVDR	EUDAMED record Report an error
Lyme antibody igg	W0105010603	Seraline® Anti-Borrelia-8 IgG2 refs98/79 SeraSpot® Anti-Borrelia IgG3 refs SeraSpot® Anti-Borrelia-10 IgG3 refs98/79	B IVDR, 98/79	EUDAMED record Report an error
Lyme antibody igm	W0105010604	Seraline® Anti-Borrelia-8 IgM2 refs98/79 SeraSpot® Anti-Borrelia IgM3 refs SeraSpot® Anti-Borrelia-10 IgM3 refs98/79	B IVDR, 98/79	EUDAMED record Report an error
Parvovirus b 19	W0105040609	SeraSpot® Anti-Parvovirus-5 IgM2 refs98/79 SeraSpot® Anti-Parvovirus-6 IgG2 refs98/79	– 98/79	EUDAMED record Report an error
Adenovirus	W0105040601	Serazym® Adenovirus98/79	– 98/79	EUDAMED record Report an error
Astrovirus	W0105040629	Serazym® Astrovirus98/79	– 98/79	EUDAMED record Report an error
Bacteriology immunoassay - other	W0105011799	Serazym® Anti-Francisella tularensis98/79	– 98/79	EUDAMED record Report an error
C.difficile GDH detection	W0105011801	Serazym® Clostridium difficile GDH98/79	– 98/79	EUDAMED record Report an error
C.difficile toxin a/b detection	W0105011802	Serazym® Clostridium difficile Toxin A+B98/79	– 98/79	EUDAMED record Report an error
Campylobacter direct antigen detection	W0105011401	Serazym® Campylobacter98/79	– 98/79	EUDAMED record Report an error
Cryptosporidium	W0105050207	Serazym® Cryptosporidium parvum98/79	– 98/79	EUDAMED record Report an error
E. coli toxin	W0105011502	Serazym® Verotoxin 1+298/79	– 98/79	EUDAMED record Report an error
Ebv igg - total	W010504040102	SeraSpot® Anti-EBV-4 IgG2 refs98/79	– 98/79	EUDAMED record Report an error
Ebv igm - total	W010504040103	SeraSpot® Anti-EBV-3 IgM2 refs98/79	– 98/79	EUDAMED record Report an error
Entamoeba histolytica	W0105050201	Serazym® Entamoeba histolytica98/79	– 98/79	EUDAMED record Report an error
Giardia lamblia	W0105050208	Serazym® Giardia98/79	– 98/79	EUDAMED record Report an error
H. pylori antigen detection	W0105010401	Serazym® H. pylori 2nd Gen.98/79	– 98/79	EUDAMED record Report an error
Norovirus	W0105040616	Serazym® Norovirus98/79	– 98/79	EUDAMED record Report an error
Rotavirus	W0105040606	Serazym® Rotavirus98/79	– 98/79	EUDAMED record Report an error
Syphilis antibody igg	W0105010303	SeraSpot® Anti-Treponema-4 IgG2 refs98/79	– 98/79	EUDAMED record Report an error
Syphilis antibody igm	W0105010304	SeraSpot® Anti-Treponema-4 IgM2 refs98/79	– 98/79	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

Didn't find it?

Tell us what you are looking for. Requests show us which categories to add first.