Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA Pre-Market Approval

FDA Class 3 ·EXABLATE 2100 SYSTEM

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA Pre-Market Approval

FDA Class 3 ·Exablate 2100/2100 VI System

STERYLAB S.R.L.

Manufacturer

🇮🇹 Italy·1 Basic UDI-DI·1 Device·ITALCERT SRL, ITALCERT SRL, ITALCERT SRL, ITALCERT SRL, and ITALCERT SRL

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'

FONDAZIONE CENTRO NAZIONALE DI ADROTERAPIA ONCOLOGICA

Manufacturer

🇮🇹 Italy·3 Basic UDI-DIs·6 Devices·ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', and ISTITUTO SUPERIORE DI SANITA'

In-Bore MRI cinema

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Kryptonite Solutions·1 device

MRI Patient Trolley

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Kryptonite Solutions·1 device

MRI Wheelchair

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Kryptonite Solutions·1 device

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.

Aflofarm Farmacja Polska Sp. z o.o.

Manufacturer

🇵🇱 Poland·3 Basic UDI-DIs·4 Devices·TUV NORD Polska Sp. z o.o, POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

EVOLUTIS

Manufacturer

🇫🇷 France·11 Basic UDI-DIs·109 Devices·ITALCERT SRL, ITALCERT SRL, ITALCERT SRL, ITALCERT SRL, and ITALCERT SRL

Acutus Medical, Inc.

Manufacturer

🇺🇸 United States·4 Basic UDI-DIs·24 Devices·1 Importer·DQS Medizinprodukte GmbH, DQS Medizinprodukte GmbH, DQS Medizinprodukte GmbH, DQS Medizinprodukte GmbH, DQS Medizinprodukte GmbH, and DQS Medizinprodukte GmbH

SpyGlass Discover Imager II IOC Catheter

FDA registration

Teleflex LLC (NADC)·1 product·🇺🇸 United States

Pediatric Two-Lumen Hemodialysis Catheterization Set/Kit with Blue FlexTip Catheter

FDA registration

Teleflex LLC (NADC)·1 product·🇺🇸 United States

PILLING

FDA registration

Teleflex LLC (NADC)·1 product·🇺🇸 United States