260739-2018-CE-NOR-NA-PS

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MDD Annex II (excluding section 4)·Intelligent Hearing Systems Corp.·DNV Product Assurance AS·1 Basic UDI-DI

US19/819943475

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MDD Annex II (excluding section 4)·Graham Medical Technologies, LLC dba GraMedica·SGS Belgium NV·1 Basic UDI-DI

41371607-02

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MDD Annex V·AccuTech Medical Technologies Inc.·INTERTEK SEMKO AB·13 Basic UDI-DIs

V1 101298 0002

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IVDD Annex IV (excluding sections 4, 6)·SHENZHEN YHLO BIOTECH CO., LTD.·TÜV SÜD Product Service GmbH·2 Basic UDI-DIs

1434-IVDD-238/2022

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IVDD Annex III Section 6·BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

1434-IVDD-010/2022

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IVDD Annex III Section 6·Jiangsu Mole Bioscience Co., LTD.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·2 Basic UDI-DIs

993928CE01

Certificate

MDD Annex II (excluding section 4)·Nutricia Medical Devices BV·DEKRA Certification B.V.·1 Basic UDI-DI

FI20/07020

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MDD Annex V·Guangzhou Longest Science & Technology Co., Ltd.·SGS FIMKO OY·2 Basic UDI-DIs

CN14-41109

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MDD Annex II (excluding section 4)·Guangzhou Longest Science & Technology Co., Ltd.·SGS Belgium NV·1 Basic UDI-DI

CN19-41109

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MDD Annex II (excluding section 4)·Guangzhou Longest Science & Technology Co., Ltd.·SGS Belgium NV·1 Basic UDI-DI

2181543CE01

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MDD Annex II (excluding section 4)·ScreenPoint Medical·DEKRA Certification B.V.·2 Basic UDI-DIs

CE683210

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MDD Annex II (excluding section 4)·Blink Device Company·BSI Group The Netherlands B.V.·6 Basic UDI-DIs

CE 19995

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MDD Annex II (excluding section 4)·OrbusNeich Medical, B.V.·BSI Group The Netherlands B.V.·1 Basic UDI-DI

CE 619995

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

CE 613049

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MDD Annex II (excluding section 4)·Dongguan Kewei Medical Instrument Co., Ltd.·BSI Group The Netherlands B.V.·135 Basic UDI-DIs

CE 623392

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MDD Annex II Section 4·Dongguan Kewei Medical Instrument Co., Ltd.·BSI Group The Netherlands B.V.·63 Basic UDI-DIs

CE 677889

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MDD Annex II Section 4·Dongguan Kewei Medical Instrument Co., Ltd.·BSI Group The Netherlands B.V.·13 Basic UDI-DIs

CE 677886

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MDD Annex II Section 4·Dongguan Kewei Medical Instrument Co., Ltd.·BSI Group The Netherlands B.V.·10 Basic UDI-DIs

CE 623391

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MDD Annex II Section 4·Dongguan Kewei Medical Instrument Co., Ltd.·BSI Group The Netherlands B.V.·49 Basic UDI-DIs

3902997TD01

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MDR Technical Documentation·BioProtect·DEKRA Certification B.V.·1 Basic UDI-DI