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Appendix Rev.1 to 240230-2017-CE-BRA-NA-PS
Certificate
MDD Annex II (excluding section 4)·Medicone Projetos e Solucoes para a Industria e a Saude Ltda.·DNV Product Assurance AS·1 Basic UDI-DI
US21/819944231
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MDD Annex II (excluding section 4)·HydraFacial, LLC·SGS Belgium NV·3 Basic UDI-DIs
MRA Q00068
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MDD Annex II (excluding section 4)·Ellex Medical Pty Ltd·THERAPEUTIC GOODS ADMINISTRATION·15 Basic UDI-DIs
CE618251
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MDD Annex II (excluding section 4)·Med-Logics, Inc.·BSI Group The Netherlands B.V.·114 Basic UDI-DIs
US21/819944231
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MDD Annex II (excluding section 4)·HydraFacial, LLC·SGS Belgium NV·1 Basic UDI-DI
CE 671277
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MDD Annex II Section 4·United Orthopedic Corporation·BSI Group The Netherlands B.V.·161 Basic UDI-DIs
CE 671278
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MDD Annex II Section 4·United Orthopedic Corporation·BSI Group The Netherlands B.V.·61 Basic UDI-DIs
243633-2017-CE-KOR-NA-PS, C679942
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MDD Annex II (excluding section 4)·OSSTEM IMPLANT Co., Ltd. Chair Business·DNV Product Assurance AS·2 Basic UDI-DIs
9746-2017-CE-KOR-NA-PS
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MDD Annex II (excluding section 4)·OSSTEM IMPLANT CO.,LTD·DNV Product Assurance AS·3 Basic UDI-DIs
9746-20217-CE-KOR-NA-PS
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MDD Annex II (excluding section 4)·OSSTEM IMPLANT CO.,LTD·DNV Product Assurance AS·1 Basic UDI-DI
CL 004717 0003
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MDD Annex II (excluding section 4)·SHENZHEN YKD TECHNOLOGY CO.,LTD.·TÜV SÜD Product Service GmbH·19 Basic UDI-DIs
CL0047170003
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MDD Annex II (excluding section 4)·SHENZHEN YKD TECHNOLOGY CO.,LTD.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI
10000328121-PA-NA-TWN
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MDD Annex II (excluding section 4)·Geon Corporation·DNV Product Assurance AS·10 Basic UDI-DIs
HD 60135526
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MDD Annex II (excluding section 4)·Hangzhou Hua’an Medical & Health Instruments Co., Ltd.·TÜV Rheinland LGA Products GmbH·2 Basic UDI-DIs
CeCert/068/W/E.2
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IVDD Annex III Section 6·Hangzhou Laihe Biotech Co., Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI
V1 076482 0004
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IVDD Annex IV (excluding sections 4, 6)·Shanghai Chemtron Biotech Co., Ltd.·TÜV SÜD Product Service GmbH·7 Basic UDI-DIs
G1 067628 0031
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MDD Annex II (excluding section 4)·Zhejiang Haisheng Medical Device Co., Ltd.·TÜV SÜD Product Service GmbH·11 Basic UDI-DIs
G1 024213 0125
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MDD Annex II (excluding section 4)·TOP Corporation·TÜV SÜD Product Service GmbH·20 Basic UDI-DIs
No.V1 076482 0004
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IVDD Annex IV (excluding sections 4, 6)·Shanghai Chemtron Biotech Co., Ltd.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI
HD 2339568-1
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MDD Annex II (excluding section 4)·DELBIO INC.·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI