Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·DIASORIN ETI-AB-HAVK PLUS ASSAY

H-EKA 2080/Y

Device

EU MDR · Eu Md Class 1 ·AGA Sanitätsartikel GmbH·On the market·32 countries

H-EKA 2080/E

Device

EU MDR · Eu Md Class 1 ·AGA Sanitätsartikel GmbH·On the market·32 countries

H-EKA 1080/E

Device

EU MDR · Eu Md Class 1 ·AGA Sanitätsartikel GmbH·On the market·32 countries

H-EKA 2065/Y

Device

EU MDR · Eu Md Class 1 ·AGA Sanitätsartikel GmbH·On the market·32 countries

H-EKA 2065/H

Device

EU MDR · Eu Md Class 1 ·AGA Sanitätsartikel GmbH·On the market·32 countries

H-EKA 1065/Y

Device

EU MDR · Eu Md Class 1 ·AGA Sanitätsartikel GmbH·On the market·32 countries

H-EKA 1065/H

Device

EU MDR · Eu Md Class 1 ·AGA Sanitätsartikel GmbH·On the market·32 countries

VIVA (HBF-222T-EBK)

Device

EU MDR · Eu Md Class 1 ·OMRON Healthcare Co., Ltd.·On the market·22 countries

H-EKA 2080/H

Device

EU MDR · Eu Md Class 1 ·AGA Sanitätsartikel GmbH·On the market·32 countries

H-EKA 1080/Y

Device

EU MDR · Eu Md Class 1 ·AGA Sanitätsartikel GmbH·On the market·32 countries

H-EKA 1080/H

Device

EU MDR · Eu Md Class 1 ·AGA Sanitätsartikel GmbH·On the market·32 countries

H-EKA 1065/E

Device

EU MDR · Eu Md Class 1 ·AGA Sanitätsartikel GmbH·On the market·32 countries

OHDAE Corporation

Manufacturer

🇰🇷 South Korea·9 Basic UDI-DIs·9 Devices

VASSEN

Manufacturer

🇰🇷 South Korea

Incuram

Manufacturer

🇰🇷 South Korea·15 Basic UDI-DIs·15 Devices·1 Importer·UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.

Goodpl Inc.

Manufacturer

🇰🇷 South Korea

SG Healthcare Co.,Ltd

Manufacturer

🇰🇷 South Korea

Truabutment Inc.

Manufacturer

🇰🇷 South Korea

TruAbutment Inc.

Manufacturer

🇺🇸 United States·1 Basic UDI-DI·46 Devices