Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR

FIC-CGSW

Basic UDI-DI

EU IVDD · Eu Ivd General ·NanoEntek, Inc.·1 device

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK/CALIBRATOR

Dental Components Sebastian Gałat

Importer

🇵🇱 Poland·1 Manufacturer

FCL Science B.V.

Importer

🇳🇱 Netherlands

FBI Medizintechnik GmbH

Importer

🇩🇪 Germany·1 Manufacturer

1434-MDD-365/2021

Certificate

MDD Annex II (excluding section 4)·FCU Co., Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

LEONE SPA

FDA UDI

LEONE SPA·08033707077763·LINGUAL BRACKET 1 ARCH IDEA-L 18 4/4KIT

STEROID-SKREEN

FDA UDI

BIOCHEMICAL DIAGNOSTICS INC·00810042681873·CLINI-SKREEN COLUMNS, 50PK

STEROID-SKREEN

FDA UDI

BIOCHEMICAL DIAGNOSTICS INC·00810042681941·POTASSIUM HYDROXIDE, 7N, 2.0L

STEROID-SKREEN

FDA UDI

BIOCHEMICAL DIAGNOSTICS INC·00810042681910·POTASSIUM HYDROXIDE, 7N, 450mL

STEROID-SKREEN

FDA UDI

BIOCHEMICAL DIAGNOSTICS INC·00810042681705·CLINI-SKREEN COLUMNS 500PK

STEROID-SKREEN

FDA UDI

BIOCHEMICAL DIAGNOSTICS INC·00810042682375·COLUMN ACTIVATOR A, 40mL

STEROID-SKREEN

FDA UDI

BIOCHEMICAL DIAGNOSTICS INC·00810042682368·COLUMN ACTIVATOR A, 400mL

DENTAL COMPONENTS EUROPE

Authorized representative

🇫🇷 France·1 Manufacturer·2 Devices

Cliniview

FDA 510(k)

FDA Class 2 ·Radiology

ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS)

FDA 510(k)

FDA Class 2 ·Orthopedic

ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.)

FDA 510(k)

FDA Class 2 ·Orthopedic

E-EEGX, N-EEGX

FDA 510(k)

FDA Class 2 ·Neurology

ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM

FDA 510(k)

FDA Class 2 ·Orthopedic