K200051 - BEUDAMED

BEUDAMED

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1,881 results · 40ms · Sources: EU EUDAMED, US FDA

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FDA registration 2k FDA UDI 13 FDA 510(k) 3 FDA classification 3 Basic UDI-DI 1 + More Filters

Country

China 685 Australia 587 Singapore 546 Japan 38 United States 22 France 1 South Korea 1 Taiwan 1 + More Countries

Manufacturer

Osstem Orthodontics Inc. 1 + More Manufacturers

Competent Authority

Ministry Of Health, Welfare And Sports 1 + More Competent Authorities

Classification

FDA Class 2 4 FDA Unclassified 2 Eu Md Class 2a 1 + More Classifications

Notified Body

Szutest Uygunluk Değerlendirme A.ş. 1 + More Notified Bodies

FDA FEI Number

3035366890 587 3015207155 583 3013176080 546 3008808082 93 3012725451 38 3005669815 5 1417592 4 1921846 4 3000268902 4 3001124136 4 3001236905 4 3002806469 4 3002807391 4 3005674464 4 3007289408 4 3011689956 4 3012421607 4 3013764800 4 3014300750 4 3016705853 4 + More FDA FEI Numbers

Regulation

Us FDA 2k Eu Mdd 1 + More Regulations

Authorized Representative

Ar Experts B.V. 1 Certification Experts 1 + More Authorized Representatives

FDA Registration Number

3035366890 587 3015207155 583 3013176080 546 3008808082 93 3012725451 38 3005669815 5 1417592 4 1423537 4 1921846 4 3000268902 4 3001124136 4 3005674464 4 3007289408 4 3011689956 4 3012421607 4 3013764800 4 3014300750 4 3016705853 4 9610825 4 9610849 4 + More FDA Registration Numbers

FDA K Number

K000051 1 K000273 1 K000464 1 K000851 1 K001023 1 K001178 1 K001519 1 K002268 1 K002466 1 K002599 1 K002896 1 K002909 1 K003047 1 K003209 1 K003229 1 K004028 1 K010447 1 K010951 1 K011150 1 K011289 1 + More FDA K Numbers

Certificate Type

Mdd Annex Ii (Excluding Section 4) 1 + More Certificate Types

Dressing, Wound, Drug

FDA classification

FDA Unclassified ·Dressing, Wound, Drug

<1 …91 92 93 94 95 >

Data last updated 04 / 2026. Visit the official EUDAMED website for up-to-date data.

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EU MDR

EU MDR Medical Devices EU MDR Active Medical Devices EU MDR Class I Medical Devices EU MDR Class I Software Devices EU MDR Class IIa Medical Devices EU MDR Class IIa Software Devices EU MDR Class IIb Medical Devices EU MDR Class IIb Software Devices EU MDR Class III Medical Devices EU MDR Class III Software Devices EU MDR Implantable Medical Devices EU MDR Measuring Function Medical Devices EU MDR Software Medical Devices

EU IVDR

EU IVDR In Vitro Diagnostic Devices EU IVDR Class A In Vitro Diagnostic Devices EU IVDR Class A Software Devices EU IVDR Class B In Vitro Diagnostic Devices EU IVDR Class B Software Devices EU IVDR Class C In Vitro Diagnostic Devices EU IVDR Class C Software Devices EU IVDR Class D In Vitro Diagnostic Devices EU IVDR Class D Software Devices EU IVDR Instrument Devices EU IVDR Kit Devices EU IVDR Reagent Devices EU IVDR Software Devices

FDA

FDA Medical Devices FDA Class I Medical Devices FDA Class II Medical Devices FDA Class III Medical Devices

By Country

EU IVDR Medical Devices from China EU IVDR Medical Devices from France EU IVDR Medical Devices from Germany EU IVDR Medical Devices from Romania EU IVDR Medical Devices from United States EU MDR Medical Devices from China EU MDR Medical Devices from Egypt EU MDR Medical Devices from Finland EU MDR Medical Devices from France EU MDR Medical Devices from Germany EU MDR Medical Devices from Italy EU MDR Medical Devices from Pakistan EU MDR Medical Devices from Poland EU MDR Medical Devices from Spain EU MDR Medical Devices from Türkiye EU MDR Medical Devices from United Kingdom EU MDR Medical Devices from United States

Notified Bodies

BSI Group The Netherlands B.V. DEKRA Certification B.V. DNV Product Assurance AS POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. SGS Belgium NV TÜV Rheinland LGA Products GmbH TÜV SÜD Product Service GmbH UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.

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