Cutera, Inc.

Manufacturer

🇺🇸 United States·17 Basic UDI-DIs·21 Devices·2 Importers·TUV NORD Polska Sp. z o.o and TÜV NORD CERT GmbH

Huvitz Co., Ltd.

Manufacturer

🇰🇷 South Korea·16 Basic UDI-DIs·47 Devices·4 Importers·TÜV Rheinland LGA Products GmbH

Amalgam Rx, Inc

Manufacturer

🇺🇸 United States·Intertek Medical Notified Body AB

Acutus Medical, Inc.

Manufacturer

🇺🇸 United States·DQS Medizinprodukte GmbH

Novocure GmbH

Manufacturer

🇨🇭 Switzerland·1 Importer·TÜV Rheinland LGA Products GmbH

Alleva Medical Limited

Manufacturer

🇨🇳 China·1 Importer·UDEM Adriatic d.o.o.

2975-MED-2501401

Certificate

MDR QMS·DMS DENTAL MEDIKAL SANAYI VE TICARET ANONIM SIRKETI·SZUTEST Konformitätsbewertungsstelle GmbH

28620177096

Certificate

MDR QMS·Amalgam Rx, Inc·Intertek Medical Notified Body AB

TNP/MDR/0029/5488/2025

Certificate

MDR QMS·Cutera, Inc.·TUV NORD Polska Sp. z o.o

HZ 2020221-1

Certificate

MDR QMS·Huvitz Co., Ltd.·TÜV Rheinland LGA Products GmbH

1000165613

Certificate

MDR QMS·Acutus Medical, Inc.·DQS Medizinprodukte GmbH

HZ 1990188-1

Certificate

MDR QMS·Novocure GmbH·TÜV Rheinland LGA Products GmbH

Fin-ceramica faenza spa

Manufacturer

🇮🇹 Italy·71 Basic UDI-DIs·110 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', ISTITUTO SUPERIORE DI SANITA', and ISTITUTO SUPERIORE DI SANITA'

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

S.I.I.T. srl

Manufacturer

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

DEVINTEC SAGL

Manufacturer

🇨🇭 Switzerland·4 Basic UDI-DIs·16 Devices·5 Importers·BUREAU VERITAS ITALIA S.P.A., BUREAU VERITAS ITALIA S.P.A., ISTITUTO SUPERIORE DI SANITA', and BUREAU VERITAS ITALIA S.P.A.

Shandong Lianfa Medical Plastic Products Co.,Ltd.

Manufacturer

🇨🇳 China·11 Basic UDI-DIs·90 Devices·7 Importers·TÜV Rheinland LGA Products GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

Koolcare Technology Co., Ltd.

Manufacturer

🇨🇳 China·9 Basic UDI-DIs·9 Devices·3 Importers·TÜV Rheinland LGA Products GmbH and TUV Rheinland Italia SRL

Ningbo HicRen Biotechnology Co., Ltd.

Manufacturer

🇨🇳 China·89 Basic UDI-DIs·89 Devices·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH

Xiamen Compower Medical Tech. Co., Ltd.

Manufacturer

🇨🇳 China·68 Basic UDI-DIs·452 Devices·6 Importers·TÜV Rheinland LGA Products GmbH and TÜV SÜD Product Service GmbH