4371470-03

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MDD Annex II (excluding section 4)·Shenzhen Fitfaith Technology Co., Ltd.·INTERTEK SEMKO AB·1 Basic UDI-DI

Directa AB

System producer

🇸🇪 Sweden

Brighter AB

System producer

🇸🇪 Sweden

AKLA AB

System producer

🇸🇪 Sweden

C-01-1190-724-20

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MDD Annex II (excluding section 4)·Oy Finnsusp Ab·Eurofins Electric & Electronics Finland Oy·11 Basic UDI-DIs

CE691616

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MDD Annex II Section 4·Evolan Pharma AB·BSI Group The Netherlands B.V.·1 Basic UDI-DI

CE691617

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MDD Annex II Section 4·Evolan Pharma AB·BSI Group The Netherlands B.V.·1 Basic UDI-DI

CR-03-1231-829-23

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MDR QMS·Tietoevry Sweden AB·Eurofins Electric & Electronics Finland Oy

HX 1060415-1

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IVDR QMS·Fujirebio Diagnostics AB·TÜV Rheinland LGA Products GmbH

145068-21-01-21

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MDD Annex II (excluding section 4)·Magle Chemoswed AB·CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft.·1 Basic UDI-DI

CE 673331

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MDD Annex II (excluding section 4)·Flow Neuroscience AB·BSI Group The Netherlands B.V.·1 Basic UDI-DI

D1001800089

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MDD Annex II Section 4·Bohus BioTech AB·MDC MEDICAL DEVICE CERTIFICATION GMBH·2 Basic UDI-DIs

D1001800095

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MDD Annex II Section 4·Bohus BioTech AB·MDC MEDICAL DEVICE CERTIFICATION GMBH·4 Basic UDI-DIs

CE683722

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MDD Annex II (excluding section 4)·Breas Medical AB·BSI Group The Netherlands B.V.·22 Basic UDI-DIs

K-2024/83

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MDD Annex II (excluding section 4)·Magle Chemoswed AB·CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft.·1 Basic UDI-DI

D1001800076

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MDD Annex II (excluding section 4)·Bohus BioTech AB·MDC MEDICAL DEVICE CERTIFICATION GMBH·29 Basic UDI-DIs

D1001800117

Certificate

MDD Annex II (excluding section 4)·Bohus BioTech AB·MDC MEDICAL DEVICE CERTIFICATION GMBH·30 Basic UDI-DIs

D1001800108

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MDD Annex II Section 4·Bohus BioTech AB·MDC MEDICAL DEVICE CERTIFICATION GMBH·3 Basic UDI-DIs

D1001800093

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MDD Annex II Section 4·Bohus BioTech AB·MDC MEDICAL DEVICE CERTIFICATION GMBH·9 Basic UDI-DIs

D1001800099

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MDD Annex II Section 4·Bohus BioTech AB·MDC MEDICAL DEVICE CERTIFICATION GMBH·1 Basic UDI-DI