QCT-0120-19

Certificate

MDD Annex II (excluding section 4)·G P S S.R.L. ·ISTITUTO SUPERIORE DI SANITA'·3 Basic UDI-DIs

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NeuroPace RNS System

Cinterqual-Soluções de Comércio Internacional,Lda.

Authorized representative

🇵🇹 Portugal·15 Manufacturers·1201 Devices

DPY - P.F.C., PFC ULTIMA HIP SYSTEM TRIAL (85592X), Device Listing: Q019772

FDA registration

PERRYMAN COMPANY·1 product·🇺🇸 United States

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·FRONTIER/FRONTIER II FAMILY OF CRT-PS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SENSOLOG/DIALOG/REGENCY FAMILT OF PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PROMOTE CRT-D; CADENCE FAMILY OF ICDS

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·CURRENT ICD; EPIC HF/ ATLAS + HF FAMILY OF CRT-DS

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MICRONY FAMILY OF PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PARAGON/PHOENIX FAMILY OF PACEMAKERS

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·OBALON BALLOON SYSTEM

Serology Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps

FDA classification

FDA Unclassified ·Serology Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps

Nucleic Acid Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps

FDA classification

FDA Unclassified ·Nucleic Acid Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval

FDA Class 3 ·Hintermann Series H3 Total Ankle Replacement System

Aridia Influenza A/B & RSV Real-Time PCR Test (REF# P0187H/L)

FDA registration

CTK BIOTECH, INC.·1 product·🇺🇸 United States

CEpartner4U

Authorized representative

🇳🇱 Netherlands·160 Manufacturers·5787 Devices

Kingsmead Service B.V.

Authorized representative

🇳🇱 Netherlands·243 Manufacturers·2698 Devices

Platinum

FDA UDI

SUMMUS MEDICAL LASER, LLC·B679SLP4H0·Light weight (~2.5 Kg.) and portable therapeuti...