RFBio Co., Ltd

Manufacturer

🇰🇷 South Korea·3 Basic UDI-DIs·3 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

ACCUSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

APA Oxy Blade

FDA 510(k)

FDA Class 1 ·Anesthesiology

Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mm

FDA 510(k)

FDA Class 2 ·Anesthesiology

Venner PneuX™ ETT (Endotracheal Tube) 6 mm, Venner PneuX™ ETT (Endotracheal Tube) 7 mm, Venner PneuX™ ETT (Endotracheal Tube) 8 mm, Venner PneuX™ ETT (Endotracheal Tube) 9 mm

FDA 510(k)

FDA Class 2 ·Anesthesiology

ACCUSIGN DOA2, DOA, BAR/BZO, BIOSIGN DOA2, BAR/BZO, STATUS DS BAR/BZO, SYVA RAPIDTEST D.A.U. 2 BAR/BZO

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Benzodiazepines (BZO) Rapid Test

Device

EU IVDD · Eu Ivd General ·Beijing Jinwofu Bioengineering Technology Co., Ltd.·On the market

Benzodiazepine(BZO) Rapid Test

Device

EU IVDD · Eu Ivd General ·VivaChek Biotech (Hangzhou) Co., Ltd.·On the market

Benzodiazepine(BZO) Rapid Test

Device

EU IVDD · Eu Ivd General ·VivaChek Biotech (Hangzhou) Co., Ltd.·On the market

Cholesterol and Calcium EasyRA reag

FDA registration

MEDICA CORP.·2 products·🇺🇸 United States

VITROS Ca Slides

FDA registration

ORTHO-CLINICAL DIAGNOSTICS, INC.·2 products·🇺🇸 United States

VITROS Ca Slides

FDA registration

ORTHO-CLINICAL DIAGNOSTICS, INC.·2 products·🇺🇸 United States

VITROS Ca Slides

FDA registration

ORTHO-CLINICAL DIAGNOSTICS, INC.·2 products·🇺🇸 United States

VITROS Ca Slides

FDA registration

ORTHO-CLINICAL DIAGNOSTICS, INC.·2 products·🇺🇸 United States

VITROS Ca Slides

FDA registration

Ortho Clinical Diagnostics, K.K.·2 products·🇯🇵 Japan

VITROS Ca Slides

FDA registration

Ortho Clinical Diagnostics·2 products·🇸🇬 Singapore

VITROS Ca Slides

FDA registration

Ortho-Clinical Diagnostics European Support Center·2 products·🇫🇷 France

Yumizen C1200 Calcium AS

FDA registration

HORIBA ABX SAS·2 products·🇫🇷 France

Hytrel Hose, 15F/15T, 60cm, Blue

FDA registration

GaleMed (Xiamen) Co., Ltd.·1 product·🇨🇳 China

SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)

FDA registration

EXCELERON MEDICAL·1 product·🇺🇸 United States