EVOLUTIS

Manufacturer

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

BNC KOREA, Inc.

Manufacturer

🇰🇷 South Korea·60 Basic UDI-DIs·60 Devices·3EC International a.s., 3EC International a.s., and 3EC International a.s.

Shenzhen Kentro Medical Electronics CO.,LTD.

Manufacturer

🇨🇳 China·5 Basic UDI-DIs·16 Devices·2 Importers·Intertek Medical Notified Body AB, INTERTEK SEMKO AB, and INTERTEK SEMKO AB

ATENA LUX S.R.L.

Manufacturer

🇮🇹 Italy·30 Basic UDI-DIs·30 Devices·ITALCERT SRL, ITALCERT SRL, and ITALCERT SRL

M.2020.106.13429

Certificate

MDD Annex II (excluding section 4)·MMT MERAN MEDİKAL TEKNOLOJİ KOLL. ŞTİ. Ahmet Cemil Baytaş ve Fatma Baytaş·UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.·1 Basic UDI-DI

Hamilton Bonaduz AG

Manufacturer

🇨🇭 Switzerland·92 Basic UDI-DIs·92 Devices·7 Importers·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products 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

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

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·CARELINK PERSONAL SOFTWARE

PROHS Equipamento Hospitalar e Serviços Associados S.A.

Manufacturer

🇵🇹 Portugal·45 Basic UDI-DIs·92 Devices·SGS Belgium NV, SGS Belgium NV, SGS Belgium NV, and SGS Belgium NV

Panin Srl

Manufacturer

🇮🇹 Italy·8 Basic UDI-DIs·8 Devices·BUREAU VERITAS ITALIA S.P.A., ISTITUTO SUPERIORE DI SANITA', KIWA CERMET ITALIA S.P.A., and KIWA CERMET ITALIA S.P.A.

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

Vertex-Dental B.V.

Manufacturer

🇳🇱 Netherlands·30 Basic UDI-DIs·51 Devices·SGS Belgium NV, SGS Belgium NV, SGS Belgium NV, and SGS Belgium NV

QMD Services GmbH

Notified body

🇦🇹 Austria·6 Manufacturers·1 Basic UDI-DI

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

A.T.S. Applicazione Tecnologie Speciali s.r.l.

Manufacturer

🇮🇹 Italy·55 Basic UDI-DIs·55 Devices·TUV Rheinland Italia SRL, IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A., IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A., IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A., and IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.

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.

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'