SURGI-PAP KIT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PAP ANTIBODY KIT

FDA 510(k)

FDA Class 2 ·Immunology

PAP SMEAR KIT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VIGOR DR/SR/DISCOVER/MERIDIAN/PDP

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VIGOR DR/SR/DISCOVER/MERIDIAN/PDP

Babi.Plus

FDA UDI

GALEMED CORPORATION·04710810105265·

Babi.Plus

FDA UDI

GALEMED CORPORATION·04710810093579·

INFUSION SET TYPE S

FDA 510(k)

FDA Class 2 ·General Hospital

SCALP VEIN SET

FDA 510(k)

FDA Class 2 ·General Hospital

SCALP VEIN SET

FDA 510(k)

FDA Class 2 ·General Hospital

DISP. SYRINGES: 2,5 & L0 MI.

FDA 510(k)

FDA Class 2 ·General Hospital

BLOOD ADMINISTRATION TYPE R

FDA 510(k)

FDA Class 2 ·General Hospital

INFUSION SET TYPE J

FDA 510(k)

FDA Class 2 ·General Hospital

BLOOD COLLECTION SET TYPE H

FDA 510(k)

FDA Class 2 ·General Hospital

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VIGOR DR/SR & DISCOVER/MERIDIAN, PDP

Li Ion Battery, PAP Device Cable

Device

EU MDR · Eu Md Class 1 ·Respironics Inc.·On the market·27 countries

Positive Airway Pressure System(PAP System)

Device

EU MDR · Eu Md Class 2a ·Resvent Medical Technology Co., Ltd·On the market·2 countries

Total Cholesterol Kit (CHOD-PAP Method)

Device

EU IVDD · Eu Ivd General ·MedicalSystem Biotechnology Co., Ltd.·On the market

Phencyclidine Reagent (PCP 1 x 250)

Device

EU IVDD · Eu Ivd General ·Beckman Coulter Inc.·On the market·32 countries

Liquid Blocker (PAP olovka), 1 komad

Device

EU IVDR · Eu Ivd Class A ·BioGnost Ltd.·On the market·32 countries