XENIA REPLY S.r.l.

Manufacturer

🇮🇹 Italy·1 Basic UDI-DI·1 Device·ICIM S.P.A.

New Idem Srl

Manufacturer

🇮🇹 Italy·ICIM S.P.A.

Saeg srl

Manufacturer

🇮🇹 Italy·ICIM S.P.A.

WORLD WORK SRL

Manufacturer

🇮🇹 Italy·ICIM S.P.A.

ENABLE INNOVATIONS SRL

Manufacturer

🇮🇹 Italy·ICIM S.P.A.

U-Care Medical Srl

Manufacturer

🇮🇹 Italy·ICIM S.P.A.

0425-MDR-030055-00

Certificate

MDR QMS·U-Care Medical Srl·ICIM S.P.A.

0425-MDR-030020-00

Certificate

MDR QMS·ENABLE INNOVATIONS SRL·ICIM S.P.A.

0425-MDR-030041-00

Certificate

MDR QMS·New Idem Srl·ICIM S.P.A.

0425-MDR-030033-00

Certificate

MDR QMS·XENIA REPLY S.r.l.·ICIM S.P.A.

0425-MDR-030024-00

Certificate

MDR QMS·Saeg srl·ICIM S.P.A.

0425-MDR-030015-00

Certificate

MDR QMS·WORLD WORK SRL·ICIM S.P.A.

M.2024.MDR.1037

Certificate

MDR QMS·Dentimplant Medikal Sağlık İç Dış Ticaret Sanayi Limited Şirketi·UDEM Adriatic d.o.o.

ICIM S.P.A.

Notified body

🇮🇹 Italy·32 Manufacturers·86 Basic UDI-DIs

1000169818

Certificate

MDR QMS·Perflow Medical Ltd.·DQS Medizinprodukte GmbH

Jiangsu Konsung Bio-Medical Science And Technology Co.,Ltd.

Manufacturer

🇨🇳 China·86 Basic UDI-DIs·107 Devices·5 Importers·TÜV Rheinland LGA Products GmbH, SGS Belgium NV, and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.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

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

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.

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