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

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE

Zrinski Solution GbR

Manufacturer

🇩🇪 Germany·1 Basic UDI-DI·1 Device·UDEM Adriatic d.o.o., UDEM Adriatic d.o.o., and UDEM Adriatic d.o.o.

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

FDA Pre-Market Approval

FDA Class 3 ·OVATIO CRT SYSTEM

Osteopore International Pte Ltd

Manufacturer

🇸🇬 Singapore·5 Importers·TÜV Rheinland LGA Products GmbH

SinoVision Healthcare (Yangzhou) Co., Ltd.

Manufacturer

🇨🇳 China·2 Basic UDI-DIs·2 Devices·TÜV Rheinland LGA Products GmbH

Smart Soft Healthcare

Manufacturer

🇧🇬 Bulgaria·1 Basic UDI-DI·1 Device·Kiwa Dare B.V.

BIOSTER, a.s.

Manufacturer

🇨🇿 Czechia·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390

newbox medical GmbH

Manufacturer

🇩🇪 Germany·SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ

Ningbo Ming Sing Optical R&D Co., Ltd.

Manufacturer

🇨🇳 China·6 Basic UDI-DIs·12 Devices·4 Importers·SGS Belgium NV

Flídr medical s.r.o.

Manufacturer

🇨🇿 Czechia·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390

Imaginalis Srl

Manufacturer

🇮🇹 Italy·1 Basic UDI-DI·2 Devices·TUV Rheinland Italia SRL

Lepu Medical Equipment (Beijing) Co., Ltd.

Manufacturer

🇨🇳 China·1 Basic UDI-DI·1 Device·SGS Belgium NV

PHARMA PRODUCT DOO

Manufacturer

🇷🇸 Serbia·SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ

MEDISEPT Spółka z ograniczoną odpowiedzialnością

Manufacturer

🇵🇱 Poland·TUV NORD Polska Sp. z o.o

Smart Blood Analytics Swiss SA

Manufacturer

🇨🇭 Switzerland·2 Basic UDI-DIs·2 Devices·SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ

MEDICAL CONSULTING SRL

Manufacturer

🇮🇹 Italy·ITALCERT SRL

Microgenics Corporation

Manufacturer

🇺🇸 United States·5 Basic UDI-DIs·5 Devices·1 Importer·TÜV Rheinland LGA Products GmbH

Gründler GmbH

Manufacturer

🇩🇪 Germany·2 Basic UDI-DIs·2 Devices·SGS FIMKO OY

RADIOLOGÍA, S.A.

Manufacturer

🇪🇸 Spain·SGS Belgium NV

SMART ALFA TEKNOLOJİ SANAYİ VE TİCARET ANONİM ŞİRKETİ

Manufacturer

🇹🇷 Türkiye·UDEM Adriatic d.o.o.