2,080 results · 20ms · Sources: EU EUDAMED, US FDA

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LSI Europe GmbH

Importer
🇩🇪 Germany

Argon Medical Production & Vertriebs Gesellschaft mbH & Co. KG

Manufacturer
🇩🇪 Germany·855 Basic UDI-DIs·855 Devices·BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., and BSI Group The Netherlands B.V.

Medprin Biotech GmbH

Manufacturer
🇩🇪 Germany·155 Basic UDI-DIs·154 Devices·BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., and BSI Group The Netherlands B.V.

NovaCutis GmbH

Manufacturer
🇩🇪 Germany·4 Basic UDI-DIs·4 Devices·BSI Group The Netherlands B.V. and BSI Group The Netherlands B.V.

IBL International GmbH

Manufacturer
🇩🇪 Germany·23 Basic UDI-DIs·29 Devices·BSI Group The Netherlands B.V.

RECIPE Chemicals + Instruments GmbH

Manufacturer
🇩🇪 Germany·74 Basic UDI-DIs·97 Devices·BSI Group The Netherlands B.V.

exocad GmbH

Manufacturer
🇩🇪 Germany·8 Basic UDI-DIs·12 Devices·BSI Group The Netherlands B.V.

orangedental GmbH & Co. KG

Manufacturer
🇩🇪 Germany·6 Basic UDI-DIs·7 Devices·BSI Group The Netherlands B.V.

Dr. Kleine Pharma GmbH

Manufacturer
🇩🇪 Germany·16 Basic UDI-DIs·17 Devices·DQS Medizinprodukte GmbH, DQS Medizinprodukte GmbH, and BSI Group The Netherlands B.V.

aricona GmbH

Importer
🇩🇪 Germany·3 Manufacturers

Freyr Life Sciences GmbH

Authorized representative
🇩🇪 Germany·18 Manufacturers·10 Devices

RT Elements Software revisions of the RT Elements applications have a specific software version number. Specifically the following RT Elements applications/versions are affected: - Cranial SRS 1.0.0 and 1.5.0 - Spine SRS 1.0.0 and 1.5.0 - Multiple Brain Mets SRS 1.5.0 - RT QA 1.0.0 and 1.5.0 Product Usage: The RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck and extracranial lesions.

FDA Enforcement
Class II ·Terminated·Brainlab AG·May 1, 2019

44232121827

Certificate
MDD Annex II (excluding section 4)·Si-tec GmbH Dental-Spezialartikel·TÜV NORD CERT GmbH·6 Basic UDI-DIs

StypCel

Device
EU MDD · Eu Md Class 3 ·Medprin Biotech GmbH·On the market·1 country

StypCel

Device
EU MDD · Eu Md Class 3 ·Medprin Biotech GmbH·On the market·1 country

StypCel

Device
EU MDD · Eu Md Class 3 ·Medprin Biotech GmbH·On the market·1 country

StypCel

Device
EU MDD · Eu Md Class 3 ·Medprin Biotech GmbH·On the market·1 country

StypCel

Device
EU MDD · Eu Md Class 3 ·Medprin Biotech GmbH·On the market·1 country

StypCel

Device
EU MDD · Eu Md Class 3 ·Medprin Biotech GmbH·On the market·1 country

StypCel

Device
EU MDD · Eu Md Class 3 ·Medprin Biotech GmbH·On the market·1 country