2,310 results · 21ms · Sources: EU EUDAMED, US FDA

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Alma IT Systems, S.L:

Manufacturer
🇪🇸 Spain·1 Basic UDI-DI·1 Device·SGS Belgium NV

Alma WORKSTATION

Device
EU MDD · Eu Md Class 2a ·Alma IT Systems, S.L:·On the market·16 countries

Arnés de Pavlik (IT)

Device
EU MDR · Eu Md Class 1 ·PRIM, S.A.·On the market

Arnés de Pavlik (IT)

Device
EU MDR · Eu Md Class 1 ·PRIM, S.A.·On the market

Arnés de Pavlik (IT)

Device
EU MDR · Eu Md Class 1 ·PRIM, S.A.·On the market

Arnés de Pavlik (IT)

Device
EU MDR · Eu Md Class 1 ·PRIM, S.A.·On the market

KROMA iT Automatic Immunological Analyzer

Device
EU IVDR · Eu Ivd Class A ·Linear Chemicals S.L.U·On the market

KROMA Plus iT Automatic Immunological Analyzer

Device
EU IVDR · Eu Ivd Class A ·Linear Chemicals S.L.U·On the market

Alma WORKSTATION

Basic UDI-DI
EU MDD · Eu Md Class 2a ·Alma IT Systems, S.L:·1 device

KROMA iT Automatic Immunological Analyzer

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Linear Chemicals S.L.U·1 device

ALLERGOFORCE SPRAY NASAL FR/DE/IT

Basic UDI-DI
EU MDD · Eu Md Class 2a ·PRANARÔM ESPAÑA S.L.U·1 device

KROMA Plus iT Automatic Immunological Analyzer

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Linear Chemicals S.L.U·1 device

ES19/86774

Certificate
MDD Annex II (excluding section 4)·Alma IT Systems, S.L:·SGS Belgium NV·1 Basic UDI-DI

Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm. It allows one to take exposures of patients in standing, sitting, or laying position.

FDA Enforcement
Class II ·Ongoing·SEDECAL SA·January 31, 2024

SM_40HF_BDC3, Mobile X-ray system

FDA Enforcement
Class II ·Ongoing·SEDECAL SA·October 29, 2025

SM_40HF_BDC, Mobile X-ray system

FDA Enforcement
Class II ·Ongoing·SEDECAL SA·October 29, 2025

SM_40HF_B_D_VIR3.004, Mobile X-ray system

FDA Enforcement
Class II ·Ongoing·SEDECAL SA·October 29, 2025

SHIMADZU RF.004, Mobile X-ray system

FDA Enforcement
Class II ·Ongoing·SEDECAL SA·October 29, 2025

Model Number 40KWMOBILE3.899, Mobile X-ray system

FDA Enforcement
Class II ·Ongoing·SEDECAL SA·October 29, 2025

SED URS LP, Mobile X-ray system

FDA Enforcement
Class II ·Ongoing·SEDECAL SA·October 29, 2025