Polydentia SA - BEUDAMED

BEUDAMED

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701 results · 70ms · Sources: EU EUDAMED, US FDA

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Device 385 FDA UDI 256 Basic UDI-DI 38 Importer 9 FDA registration 8 Manufacturer 2 Authorized representative 1 Certificate 1 FDA 510(k) 1 + More Filters

Country

Switzerland 434 United States 257 Germany 2 Liechtenstein 2 Spain 2 Finland 1 Hungary 1 Poland 1 Slovakia 1 + More Countries

Manufacturer

Polydentia Sa 434 Guilin Woodpecker Medical Instrument Co., Ltd. 6 Angelus Indústria De Produtos Odontológicos S/A 4 Garrison Dental Solutions Llc 4 Harald Nordin S.A. 4 Fairfax Medical Products Limited 3 Aegis Lifesciences Pvt. Ltd. 2 Aidite（Qinhuangdao）Technology Co.,Ltd. 2 Aseptico, Inc. 2 Asiga 2 Common Sense Dental Products 2 Danville Materials, Llc 2 Den Mat Holdings, Llc 2 Fkg Dentaire Sàrl 2 Guilin Yikeshi Medical Instrument Co., Ltd 2 Huanghua Promisee Dental Co.Ltd. 2 Inter Med, Inc. 2 Mdt Micro Diamond Technologies Ltd. 2 Meta Biomed Co., Ltd. 2 Microcopy, A Division Of Neo Flo, Inc. 2 + More Manufacturers

Competent Authority

Office Of Public Health 428 Agencia Española De Medicamentos Y Productos Sanitarios 2 De/Ca304 Marktüberwachung Medizinprodukte Bayern 1 De/Ca40 Regierungspräsidium Tübingen Referat 25 Sachgebiet Medizinprodukte 1 Finnish Medicines Agency, Supervision And Licences, Medical Device Unit 1 Nemzeti Népegészségügyi és Gyógyszerészeti Központ 1 The Office For Registration Of Medicinal Products, Medical Devices And Biocidal Products 1 štátny ústav Pre Kontrolu Liečiv / State Institute For Drug Control ( Slovak Ca) 1 + More Competent Authorities

Kind

Single Use 333 Sterilization 100 + More Kinds

Classification

Eu Md Class 1 409 Eu Md Class 2a 14 FDA Class 2 1 + More Classifications

Notified Body

Sgs Belgium Nv 16 + More Notified Bodies

FDA FEI Number

1000558210 9 1000118628 1 1000121639 1 1000123591 1 1000125917 1 1000127002 1 1000137415 1 1000243214 1 1000254146 1 1000269600 1 1000277456 1 1000293792 1 1000303432 1 1000305589 1 1000356102 1 1000486347 1 1000531402 1 1038806 1 1043617 1 1221541 1 + More FDA FEI Numbers

Regulation

Eu Mdr 409 Us FDA 265 Eu Mdd 14 + More Regulations

Authorized Representative

Idd International Dental Distributors Ag 425 + More Authorized Representatives

FDA Registration Number

8031054 8 1000118628 1 1000243214 1 1000277456 1 1000303432 1 1000486347 1 1000625496 1 1038806 1 1043617 1 1221541 1 1223843 1 1316408 1 1410097 1 1415367 1 1416675 1 1417322 1 1417846 1 1420052 1 1460656 1 1483306 1 + More FDA Registration Numbers

Certificate Type

Mdd Annex Ii (Excluding Section 4) 16 + More Certificate Types

Status

On The Market 372 No Longer On The Market 13 + More Statuses

FIBER-SPLINT ML MULTILAYER

FDA Class 2 ·Dental

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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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