PROSTHESES, FACIAL, ODONTOLOGICAL, AND CRANIAL – OTHERS [extension of the scope as of 2025-01-01]

Device

EU MDD · Eu Md Class 2b ·M.C. Medizintechnik-Export GmbH & Co. KG·On the market·6 countries

A2® short stem

Device

EU MDD · Eu Md Class 3 ·ARTIQO GmbH·On the market·2 countries

Sonata Patient Recorder

Device

EU MDD · Eu Md Class 2a ·Dr. Fenyves und Gut Deutschland GmbH·On the market·10 countries

ENDOTRACHEAL TUBE CUFFS INFLATION SYSTEMS

Device

EU MDD · Eu Md Class 2a ·Hospitech Respiration Ltd.·On the market·1 country

PROSTHESES, FACIAL, ODONTOLOGICAL, AND CRANIAL – OTHERS [extension of the scope as of 2025-01-01]

Device

EU MDD · Eu Md Class 2b ·M.C. Medizintechnik-Export GmbH & Co. KG·On the market·6 countries

PROSTHESES, FACIAL, ODONTOLOGICAL, AND CRANIAL – OTHERS [extension of the scope as of 2025-01-01]

Device

EU MDD · Eu Md Class 2b ·M.C. Medizintechnik-Export GmbH & Co. KG·On the market·6 countries

Adenosine Deaminase (ADA) Assay Kit by Enzymatic Method

Basic UDI-DI

EU IVDD · Eu Ivd General ·Maccura Biotechnology Co., Ltd. ·1 device

Adenosine Deaminase (ADA) Assay Kit by Enzymatic Method

Basic UDI-DI

EU IVDD · Eu Ivd General ·Maccura Biotechnology Co., Ltd. ·1 device

5-867-600-1907

Certificate

MDD Annex VI·MDE Kft.·NEOEMKI Nemzeti Orvostechnikai Eszköz Megfelelőségértékelő és Tanúsító Korlátolt Felelősségű Társaság (NEOEMKI LLC)·1 Basic UDI-DI

HD 60139155

Certificate

MDD Annex II (excluding section 4)·Carewill, Lda·TUV Rheinland Italia SRL·10 Basic UDI-DIs

QUALITYLINE,S.L.

Authorized representative

🇪🇸 Spain·1 Manufacturer

Soro Fisiológico

Basic UDI-DI

EU MDD · Eu Md Class 1 ·Alliande - Expert Manufacturer, Lda·1 device

Soro Fisiológico

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Alliande - Expert Manufacturer, Lda·5 devices

KinetikOS

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Kinetikos - Driven Solutions, Lda·1 device

Máscaras Cirúrgicas Tipo IIR

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Alliande - Expert Manufacturer, Lda·2 devices

Kinetikos platform

Basic UDI-DI

EU MDR · Eu Md Class 2a ·Kinetikos - Driven Solutions, Lda·1 device

mKinetikos

Basic UDI-DI

EU MDR · Eu Md Class 2a ·Kinetikos - Driven Solutions, Lda·1 device

Adriatic

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Orthos XXI, Unipessoal Lda·2 devices

CDA Haler 45 x 2.25 x 3.5 - O - V3

Basic UDI-DI

EU MDD · Eu Md Class 1 ·EMPHASYS IMPORTADORA, EXPORTADORA E DISTRIBUIDORA LTDA.·1 device

CDA Haler 45 x 1.00 x 3.5 - C - V3

Basic UDI-DI

EU MDD · Eu Md Class 1 ·EMPHASYS IMPORTADORA, EXPORTADORA E DISTRIBUIDORA LTDA.·1 device