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

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

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

GAMA GROUP a.s.

Manufacturer

🇨🇿 Czechia·164 Basic UDI-DIs·200 Devices·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, ELEKTROTECHNICKÝ ZKUŠEBNÍ ÚSTAV, s.p., ELEKTROTECHNICKÝ ZKUŠEBNÍ ÚSTAV, s.p., ELEKTROTECHNICKÝ ZKUŠEBNÍ ÚSTAV, s.p., ELEKTROTECHNICKÝ ZKUŠEBNÍ ÚSTAV, s.p., ELEKTROTECHNICKÝ ZKUŠEBNÍ ÚSTAV, s.p., ELEKTROTECHNICKÝ ZKUŠEBNÍ ÚSTAV, s.p., ELEKTROTECHNICKÝ ZKUŠEBNÍ ÚSTAV, s.p., and ELEKTROTECHNICKÝ ZKUŠEBNÍ ÚSTAV, s.p.

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

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

S.I.I.T. srl

Manufacturer

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

JIANGSU JIELE MEDICAL DRESSING CO.,LTD

Manufacturer

🇨🇳 China·12 Basic UDI-DIs·28 Devices·2 Importers·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH

Takagi seiko

Manufacturer

🇯🇵 Japan·14 Basic UDI-DIs·29 Devices·4 Importers·SGS Belgium NV, SGS FIMKO OY, SGS FIMKO OY, and SGS FIMKO OY

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

S.E. Carburos Metálicos, S.A.

Manufacturer

🇪🇸 Spain·257 Basic UDI-DIs·257 Devices·SGS Belgium NV, CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS, CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS, DNV Product Assurance AS, and DNV Product Assurance AS