DTL MEDICAL SRL

Importer

🇷🇴 Romania

HTL-Strefa S.A.

Importer

🇵🇱 Poland

BTL Industries JSC

Importer

🇧🇬 Bulgaria

FDA Pre-Market Approval

Sodium Hyaluronate Ophtalmic Viscoelastc Devices (OVD); Healon PRO, Healon5 PRO, and Healon DUet PRO Dual Pack

Extension Assy, 4" (S9SPINE-CTL - Shukla Spine/ Universal Spinal Screw Removal System)

Basic UDI-DI

EU MDR · Eu Md Class 1 ·S. S. White Technologies Inc/DBA Shukla Medical·3 devices

Driver Assy, Pentalobe, for GS Medical : For S9SPINE , Spc. Order (S9SPINE-CTL - Shukla Spine/ Universal Spinal Screw Removal System)

Device

EU MDR · Eu Md Class 1 ·S. S. White Technologies Inc/DBA Shukla Medical·On the market·4 countries

Driver Assy, Cruciform, for GS Medical : For S9SPINE , Spc. Order (S9SPINE-CTL - Shukla Spine/ Universal Spinal Screw Removal System)

Device

EU MDR · Eu Md Class 1 ·S. S. White Technologies Inc/DBA Shukla Medical·On the market·4 countries

Driver Assy, Female, Heptagon, 1/2", for Silhouette by Zimmer (S9SPINE-CTL - Shukla Spine/ Universal Spinal Screw Removal System)

Device

EU MDR · Eu Md Class 1 ·S. S. White Technologies Inc/DBA Shukla Medical·On the market·4 countries

Driver Assy, Female, Hexalobe, for Xia III by Stryker Spine (S9SPINE-CTL - Shukla Spine/ Universal Spinal Screw Removal System)

Device

EU MDR · Eu Md Class 1 ·S. S. White Technologies Inc/DBA Shukla Medical·On the market·4 countries

Driver Assy, Male, 4 prong, for Xia by Stryker Spine (S9SPINE-CTL - Shukla Spine/ Universal Spinal Screw Removal System)

Device

EU MDR · Eu Md Class 1 ·S. S. White Technologies Inc/DBA Shukla Medical·On the market·4 countries

Driver Assy, Male, Flower Shaped, for Spinelink II by EBI (S9SPINE-CTL - Shukla Spine/ Universal Spinal Screw Removal System)

Device

EU MDR · Eu Md Class 1 ·S. S. White Technologies Inc/DBA Shukla Medical·On the market·4 countries

Driver Assy, Female, Flower Shaped, for Spinelink II by EBI (S9SPINE-CTL - Shukla Spine/ Universal Spinal Screw Removal System)

Device

EU MDR · Eu Md Class 1 ·S. S. White Technologies Inc/DBA Shukla Medical·On the market·4 countries

Driver Assy, Female, Horse Shoe, For Moss-Miami by DePuy (S9SPINE-CTL - Shukla Spine/ Universal Spinal Screw Removal System)

Device

EU MDR · Eu Md Class 1 ·S. S. White Technologies Inc/DBA Shukla Medical·On the market·4 countries

Driver Assy, Female, Hex, Cap Nut Remover for Interpore Cross (S9SPINE-CTL - Shukla Spine/ Universal Spinal Screw Removal System)

Device

EU MDR · Eu Md Class 1 ·S. S. White Technologies Inc/DBA Shukla Medical·On the market·4 countries

Driver Assy, Female, Dodecagon, for Outer Nut by Depuy Spine (S9SPINE-CTL - Shukla Spine/ Universal Spinal Screw Removal System)

Device

EU MDR · Eu Md Class 1 ·S. S. White Technologies Inc/DBA Shukla Medical·On the market·4 countries

Driver Assy, Male, 3-Prong, for Nex-Link by Zimmer (S9SPINE-CTL - Shukla Spine/ Universal Spinal Screw Removal System)

Device

EU MDR · Eu Md Class 1 ·S. S. White Technologies Inc/DBA Shukla Medical·On the market·4 countries

Driver Assy, Male, 3 pronged, for Cervi-Lok by Zimmer (S9SPINE-CTL - Shukla Spine/ Universal Spinal Screw Removal System)

Device

EU MDR · Eu Md Class 1 ·S. S. White Technologies Inc/DBA Shukla Medical·On the market·4 countries

Driver Assy, Male, Flower Shaped, For Spinelink ACS by EBI (S9SPINE-CTL - Shukla Spine/ Universal Spinal Screw Removal System)

Device

EU MDR · Eu Md Class 1 ·S. S. White Technologies Inc/DBA Shukla Medical·On the market·4 countries

Driver Assy, Male, Square, Unlock tool, For Interpore by Cross (S9SPINE-CTL - Shukla Spine/ Universal Spinal Screw Removal System)

Device

EU MDR · Eu Md Class 1 ·S. S. White Technologies Inc/DBA Shukla Medical·On the market·4 countries

CL 040404 0057

Certificate

MDD Annex II (excluding section 4)·ITL Asia Pacific Sdn. Bhd.·TÜV SÜD Product Service GmbH·92 Basic UDI-DIs