CE 619995

Certificate

MDD Annex II (excluding section 4)·OrbusNeich Medical, B.V.·BSI Group The Netherlands B.V.·181 Basic UDI-DIs

NO. G10864670010 Rev.02

Certificate

MDD Annex II (excluding section 4)·Leo Medical Co., Ltd.·TÜV SÜD Product Service GmbH·2 Basic UDI-DIs

HZ 2159866-1

Certificate

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

1434-MDR-001/2024

Certificate

MDR QMS·Przedsiębiorstwo Produkcji Farmaceutycznej Hasco - Lek S.A.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

2017-MDD/QS-044/C, 2017-MDD/DE-045/C

Certificate

MDD Annex II (excluding section 4)·BNC KOREA, Inc.·3EC International a.s.·35 Basic UDI-DIs

2019-MDD/QS-020/A

Certificate

MDD Annex II (excluding section 4)·Ubiosis·3EC International a.s.·1 Basic UDI-DI

Certificate

MDR Technical Documentation·Bloomage Biotechnology Corp.,Ltd.·3EC International a.s.·1 Basic UDI-DI

2024-MDR/TD-031

Certificate

MDR Technical Documentation·Chetan Meditech Pvt. Ltd.·3EC International a.s.·1 Basic UDI-DI

2019-MDD/QS-088/A, 2019-MDD/DE-009/A

Certificate

MDD Annex II Section 4·Dalim Tissen Co., Ltd.·3EC International a.s.·9 Basic UDI-DIs

2024-MDR/QS-055, 2024-MDR/TD-055

Certificate

MDR Technical Documentation·Dalim Tissen Co., Ltd.·3EC International a.s.·1 Basic UDI-DI

2021-MDD/QS-021

Certificate

MDD Annex II (excluding section 4)·Chetan Meditech Pvt. Ltd.·3EC International a.s.·1 Basic UDI-DI

2019-MDD/QS-006/A, 2019-MDD/DE-007/A

Certificate

MDD Annex II Section 4·Dalim Tissen Co., Ltd.·3EC International a.s.·9 Basic UDI-DIs

2019-MDD/QS-006/A, 2019-MDD/DE-007/A

Certificate

MDD Annex II Section 4·Dalim Tissen Co., Ltd.·3EC International a.s.·1 Basic UDI-DI

2024-MDR/QS-056, 2024-MDR/TD-056

Certificate

MDR Technical Documentation·Dalim Tissen Co., Ltd.·3EC International a.s.·1 Basic UDI-DI

2020-MDD/QS-024

Certificate

MDD Annex II (excluding section 4)·SIA "LINLINE Medical Systems"·3EC International a.s.·2 Basic UDI-DIs

2024-MDR/QS-064

Certificate

MDR QMS·WOLF-Medizintechnik GmbH·3EC International a.s.

2024-MDR/QS-061

Certificate

MDR QMS·Elixir Medical Corporation·3EC International a.s.

2024-MDR/QS-063

Certificate

MDR QMS·ZHIVAS LTD·3EC International a.s.

2024-MDR/QS-062

Certificate

MDR QMS·ZHIVAS LTD·3EC International a.s.

2024-MDR/QS-060

Certificate

MDR QMS·Vortran Medical Technology 1 Inc.·3EC International a.s.