40 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Germany
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Karl Heck GmbH
Manufacturer
🇩🇪 Germany
Heck Hygiene GmbH
Manufacturer
🇩🇪 Germany
Heck Bio-Pharma GmbH
Manufacturer
🇩🇪 Germany
Accu-Chek
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Roche Diabetes Care GmbH·On the market·4 countries
Accu-Chek Aviva
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Roche Diabetes Care GmbH·On the market·5 countries
Accu-Chek Solo
Device
EU MDD
·
Eu Md Class 2b
·Roche Diabetes Care GmbH·On the market·8 countries
Accu-Chek Mobile
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Roche Diabetes Care GmbH·On the market·3 countries
Accu-Chek Mobile
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Roche Diabetes Care GmbH·On the market·3 countries
Accu-Chek Instant
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Roche Diabetes Care GmbH·On the market·4 countries
Accu-Chek Instant
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Roche Diabetes Care GmbH·On the market·5 countries
Accu-Chek Guide
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Roche Diabetes Care GmbH·On the market·2 countries
Accu-Chek Insight
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Roche Diabetes Care GmbH·On the market·13 countries
Accu-Chek Spirit Combo
Device
EU MDD
·
Eu Md Class 2b
·Roche Diabetes Care GmbH·On the market·4 countries
Optidrop Ultra nicht steril
Device
EU MDR
·
Eu Md Class 1
·Bad-Apotheke Henning Fichter e.K.·On the market
Heck Hygiene
Importer
🇩🇪 Germany
ACCU-CHEK INSTANT MMOL/L KIT
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·Roche Diabetes Care GmbH·1 device
Accu-Chek Solo system kit - A
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Roche Diabetes Care GmbH·1 device
Henke-Ject-2 part luer sterile single use syringes - used for intravenous, intramuscular, subcutaneous, intracutaneous and intraarterial injection of liquids or diluted drugs in combination with an adequate medical device or for withdrawal of fluids from the body. Ref: 4100.000V0
FDA Enforcement
Class II
·Ongoing·Wolf, Henke Sass, Gmbh·October 4, 2023
ACCU-CHEK Mobile Kit HCP mmol/l
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·Roche Diabetes Care GmbH·1 device
Accu-Chek Mobile LCM mmol/l HCP
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·Roche Diabetes Care GmbH·1 device