NO. G10864670010 Rev.02

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

HZ 2159866-1

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

1434-MDR-001/2024

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

MD 662930

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IVDD Annex IV (excluding sections 4, 6)·CoaguSense Inc.·BSI Assurance UK Ltd·2 Basic UDI-DIs

0086

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IVDD Annex IV (excluding sections 4, 6)·CoaguSense Inc.·BSI Assurance UK Ltd·1 Basic UDI-DI

MD662930

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IVDD Annex IV (excluding sections 4, 6)·CoaguSense Inc.·BSI Assurance UK Ltd·1 Basic UDI-DI

2195-MED-1313701

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MDD Annex V·İYON SAĞLIK MEDİKAL KOZMETİK İTHALAT İHRACAT VE SANAYİ TİCARET ANONİM ŞİRKETİ·HTCert (Health Technology Certification Ltd)·3 Basic UDI-DIs

3585C04210501

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MDD Annex II (excluding section 4)·Ortho Cape·HTCert (Health Technology Certification Ltd)·15 Basic UDI-DIs

2204C04210402

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MDD Annex II (excluding section 4)·ISO Med·HTCert (Health Technology Certification Ltd)·6 Basic UDI-DIs

n.0068/QCO-DM/039-2019

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MDD Annex II Section 4·Aysam Ortopedi ve Tıbbi Aletler Sanayi ve Ticaret Limited Şirketi·HTCert (Health Technology Certification Ltd)·13837 Basic UDI-DIs

3585c04210501

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MDD Annex II (excluding section 4)·Ortho Cape·HTCert (Health Technology Certification Ltd)·1 Basic UDI-DI

358504210501

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MDD Annex II (excluding section 4)·Ortho Cape·HTCert (Health Technology Certification Ltd)·2 Basic UDI-DIs

3585C04210501

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MDD Annex II (excluding section 4)·Ortho Cape·HTCert (Health Technology Certification Ltd)·64 Basic UDI-DIs

HİBRİT FIXATOR HALKA 2/3 ALÜMİNYUM (HYBRID FIXATOR RING 2/3 ALUMINIUM) 155 MM

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MDD Annex II Section 4·Aysam Ortopedi ve Tıbbi Aletler Sanayi ve Ticaret Limited Şirketi·HTCert (Health Technology Certification Ltd)·1 Basic UDI-DI

n.0068/QCO-DM/157-2020

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MDD Annex II (excluding section 4)·Ortimplant Ortopedi ve Tıbbi Aletleri Sanayi Ticaret Limited Şirketi·HTCert (Health Technology Certification Ltd)·4769 Basic UDI-DIs

2024/03/28

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MDD Annex II Section 4·Aysam Ortopedi ve Tıbbi Aletler Sanayi ve Ticaret Limited Şirketi·HTCert (Health Technology Certification Ltd)·1 Basic UDI-DI

1260C04200201

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MDD Annex II (excluding section 4)·SmartCardia SA·HTCert (Health Technology Certification Ltd)·2 Basic UDI-DIs

Directive 93/42/EEC Annex II section 4

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MDD Annex II Section 4·Aysam Ortopedi ve Tıbbi Aletler Sanayi ve Ticaret Limited Şirketi·HTCert (Health Technology Certification Ltd)·1 Basic UDI-DI

1237C04200401

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MDD Annex II (excluding section 4)·Smit Medimed Private Limited·HTCert (Health Technology Certification Ltd)·3 Basic UDI-DIs

1237c04200401

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MDD Annex II (excluding section 4)·Smit Medimed Private Limited·HTCert (Health Technology Certification Ltd)·1 Basic UDI-DI