HEALTHIUM MEDTECH LIMITED

Manufacturer

🇮🇳 India·1 Importer·3EC International a.s., 3EC International a.s., 3EC International a.s., 3EC International a.s., 3EC International a.s., 3EC International a.s., 3EC International a.s., 3EC International a.s., 3EC International a.s., 3EC International a.s., 3EC International a.s., 3EC International a.s., and 3EC International a.s.

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

FDA Pre-Market Approval

FDA Class 3 ·Corox OTW BP/OTW-S BP; Corox OTW-L BP/ProMRI OTW-L BP; Corox ProMRI OTW BP/ProMRI OTW-SBP; Sentus ProMRI OTW QP S/ProMRI

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

FDA Pre-Market Approval

FDA Class 3 ·Edora 8, Evity 8, Enitra 8, Enticos 8 HF-T QPs,Edora 8, Evity 8, Enitra 8, Enticos 8 HF-Ts and PSW 1601.U Pacemaker/ICD/

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·OSTEOSPACE

Chetan Meditech Pvt. Ltd.

Manufacturer

🇮🇳 India·4 Importers·3EC International a.s., 3EC International a.s., 3EC International a.s., 3EC International a.s., 3EC International a.s., and 3EC International a.s.

Block, Cutting, Ent, Non-Sterile

FDA classification

FDA Class 1 ·Block, Cutting, Ent, Non-Sterile

CHIRANA T.Injecta, a.s.

Manufacturer

🇸🇰 Slovakia·1 Basic UDI-DI·1 Device·3EC International a.s., 3EC International a.s., 3EC International a.s., and 3EC International a.s.

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

FDA Pre-Market Approval

FDA Class 3 ·PARADYM MODEL 8750 CRT-D WITH SMARTVIEW 2.16 UG2 PROGRAMMER SOFTWARE

GPI S.P.A.

Manufacturer

🇮🇹 Italy·7 Basic UDI-DIs·7 Devices·ITALCERT SRL, BUREAU VERITAS ITALIA S.P.A., and BUREAU VERITAS ITALIA S.P.A.

NTC Srl

Manufacturer

🇮🇹 Italy·ITALCERT SRL, ITALCERT SRL, and ITALCERT SRL

Euleria srl Società Benefit

Manufacturer

🇮🇹 Italy·BUREAU VERITAS ITALIA S.P.A., BUREAU VERITAS ITALIA S.P.A., and BUREAU VERITAS ITALIA S.P.A.

FREY SPÓŁKA JAWNA

Manufacturer

🇵🇱 Poland·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

UV Smart Technologies B.V.

Manufacturer

🇳🇱 Netherlands·3 Basic UDI-DIs·3 Devices·UDEM Adriatic d.o.o., UDEM Adriatic d.o.o., and UDEM Adriatic d.o.o.

UZUMCU HOSPITAL EQUIPMENT METAL PROCESSING INDUSTRY AND TRADE COMPANY

Manufacturer

🇹🇷 Türkiye·UDEM Adriatic d.o.o., UDEM Adriatic d.o.o., and UDEM Adriatic d.o.o.

Stopler-QRS groep

Importer

🇳🇱 Netherlands·18 Manufacturers

MPS Backup System (MPBUS)

FDA registration

MIDWEST STERILIZATION CORP.·5 products·🇺🇸 United States

MPS Backup System (MPBUS)

FDA registration

QUEST MEDICAL, INC.·5 products·🇺🇸 United States

GRUPPO FARMAIMPRESA SRL

Manufacturer

🇮🇹 Italy·ITALCERT SRL and ITALCERT SRL

FRI.MED. S.R.L.

Manufacturer

🇮🇹 Italy·TUV Rheinland Italia SRL and TUV Rheinland Italia SRL

InBody Co., Ltd.

Manufacturer

🇰🇷 South Korea·1 Importer·SGS Belgium NV and SGS Belgium NV