Hansol Medical Co.

Manufacturer

🇰🇷 South Korea·3 Basic UDI-DIs·51 Devices·2 Importers·SGS Belgium NV and SGS Belgium NV

TRICOMED S.A.

Manufacturer

🇵🇱 Poland·4 Basic UDI-DIs·7 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

B. & B. Dental S.r.l.

Manufacturer

🇮🇹 Italy·11 Basic UDI-DIs·22 Devices·TUV Rheinland Italia SRL, TUV Rheinland Italia SRL, ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', TUV Rheinland Italia SRL, and ISTITUTO SUPERIORE DI SANITA'

Adjunctive Open Loop Fluid Therapy Recommender

FDA classification

FDA Class 2 ·Adjunctive Open Loop Fluid Therapy Recommender

HemoSphere

FDA UDI

Edwards Lifesciences LLC·00690103197006·HemoSphere Advanced Monitor

HEMOSPHERE

FDA UDI

Edwards Lifesciences LLC·00690103199321·Pressure Cable

HEMOSPHERE FORESIGHT MODULE

FDA UDI

Edwards Lifesciences LLC·00690103208573·HEMOSPHERE FORESIGHT MODULE

HemoSphere

FDA UDI

Edwards Lifesciences LLC·00690103196993·HemoSphere Swan-Ganz Module

HemoSphere

FDA UDI

Edwards Lifesciences LLC·00690103202762·CLEARSIGHT MODULE

FORESIGHT OXIMETER CABLE

FDA UDI

Edwards Lifesciences LLC·00690103210927·FORESIGHT OXIMETER CABLE

HemoSphere Tissue Oximetry Module

FDA UDI

Edwards Lifesciences LLC·00690103200355·HemoSphere Tissue Oximetry Module

HemoSphere

FDA UDI

Edwards Lifesciences LLC·00690103196986·HemoSphere Oximetry Cable

HemoSphere Alta Advanced Monitoring Platform

FDA registration

EDWARDS LIFESCIENCES LLC·9 products·🇺🇸 United States

HemoSphere Alta Advanced Monitoring Platform

FDA registration

BECTON, DICKINSON AND COMPANY·9 products·🇺🇸 United States

BENCHMARK ELECTRONICS, INC.

FDA registration

BENCHMARK ELECTRONICS, INC.·9 products·🇺🇸 United States

PulseLavage AB

Manufacturer

🇸🇪 Sweden·5 Basic UDI-DIs·5 Devices·UDEM Adriatic d.o.o., UDEM Adriatic d.o.o., and Eurofins Electric & Electronics Finland Oy

Focus&Fusion Healthcare (Hangzhou) Co., Ltd

Manufacturer

🇨🇳 China·8 Basic UDI-DIs·87 Devices·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH

Innoventa Medica ApS

Manufacturer

🇩🇰 Denmark·3 Basic UDI-DIs·8 Devices·Intertek Medical Notified Body AB, Intertek Medical Notified Body AB, and Intertek Medical Notified Body AB

LSM-MED S.r.l.

Manufacturer

🇸🇲 San Marino·1 Basic UDI-DI·3 Devices·2 Importers·ITALCERT SRL, ITALCERT SRL, and ITALCERT SRL

ANGIOLOGICA B.M. S.R.L.

Manufacturer

🇮🇹 Italy·3 Basic UDI-DIs·3 Devices·ITALCERT SRL, ITALCERT SRL, and ITALCERT SRL