I-SMART DEVELOPMENTS LIMITED

Manufacturer

1 Basic UDI-DI·1 Device·1 Importer·Kiwa Dare B.V.

Calopad AG

Manufacturer

🇨🇭 Switzerland·BUREAU VERITAS ITALIA S.P.A.

Bonebridge AG

Manufacturer

🇨🇭 Switzerland·33 Basic UDI-DIs·185 Devices·TUV Rheinland Italia SRL

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Manufacturer

🇨🇳 China·334 Basic UDI-DIs·1887 Devices·29 Importers·SGS Belgium NV, SGS Belgium NV, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

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

BETATEX SPA

Manufacturer

🇮🇹 Italy·9 Basic UDI-DIs·9 Devices·ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

FOTONA, proizvodnja optoelektronskih naprav d.o.o.

Manufacturer

🇸🇮 Slovenia·6 Basic UDI-DIs·8 Devices·3EC International a.s. and TÜV SÜD Product Service GmbH

Shanghai United Imaging Healthcare Co.,Ltd.

Manufacturer

🇨🇳 China·55 Basic UDI-DIs·55 Devices·1 Importer·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service 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

Dongyang Songpu Latex (Jinzhou) Co., Ltd.

Manufacturer

🇨🇳 China·2 Basic UDI-DIs·50 Devices·2 Importers·TÜV Rheinland LGA Products GmbH and TÜV SÜD Product Service GmbH

Jafron Biomedical Co., Ltd.

Manufacturer

🇨🇳 China·25 Basic UDI-DIs·49 Devices·4 Importers·TÜV Rheinland LGA Products GmbH, TÜV SÜD Product Service GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH

SIFI S.p.A.

Manufacturer

🇮🇹 Italy·4 Basic UDI-DIs·819 Devices·ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', ITALCERT SRL, ITALCERT SRL, TÜV SÜD Product Service GmbH, ISTITUTO SUPERIORE DI SANITA', and ITALCERT SRL

20M00084CRT02

Certificate

MDR QMS·I-SMART DEVELOPMENTS LIMITED·Kiwa Dare B.V.

IT335406

Certificate

MDR QMS·Calopad AG·BUREAU VERITAS ITALIA S.P.A.

ITH 1343526 1

Certificate

MDR QMS·Med-Logix Srl·TUV Rheinland Italia SRL

013-00-00-MDR

Certificate

MDR QMS·LSM-MED S.r.l.·ITALCERT SRL

TNP/MDR/0012/4929/2023

Certificate

MDR QMS·MED-INSTAL Irena Ratajczak·TUV NORD Polska Sp. z o.o

ITH 2477191 1

Certificate

MDR QMS·Bonebridge AG·TUV Rheinland Italia SRL

HZ 2159866-1

Certificate

MDR QMS·Shandong Lee Med Technology Co., Ltd.·TÜV Rheinland LGA Products GmbH

TNP/MDR/0004/1127/2022

Certificate

MDR QMS·Zakład Techniki Medycznej "Tech-Med" Sp. z o.o.·TUV NORD Polska Sp. z o.o