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Medical equipment and related accessories, software and consumables
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Instruments for functional explorations and therapeutic interventions
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General and multidisciplinary surgery instruments
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Various instruments for general and multidisciplinary surgery
/
Wound treatment equipment
Wound treatment equipment
Z12019003
308 devices
RECELL GO Procedure Pack A
AVITA Medical Americas, LLC
·
,
United States
Class IIa
CE/MDR
Genadyne XLR8+ Negative PRessure Wound Therapy System
Genadyne Biotechnologies Inc.
·
,
United States
Class IIa
CE/MDD
GUDID
on market
Cyber Force
Üzümcü Hastane Eki̇pmanlari Metal İşleme Sanayi̇ Ve Ti̇caret A.Ş.
·
,
Türkiye
Class I
CE/MDR
Skin IQ MCM
Arjohuntleigh AB
·
,
Sweden
Class IIa
CE/MDR
Alpha Active 3
Arjohuntleigh AB
·
,
Sweden
Class IIa
CE/MDR
Auralis
Arjohuntleigh AB
·
,
Sweden
Class IIa
CE/MDR
Tupferstab, Gaze / Gauze
REDA Instrumente GmbH
·
,
Germany
Class I
CE/MDR
Alpha Active 3
Arjohuntleigh AB
·
,
Sweden
Class IIa
CE/MDR
Alpha Active 5
Arjohuntleigh AB
·
,
Sweden
Class IIa
CE/MDR
MolecuLight i:X
MolecuLight Inc
·
,
Canada
Class IIa
FDA 510(k)
×3
K210882
Active
FDA De Novo
DEN180008
Active
Cleared 31 Jul 2018
+1
authorizations
Skin IQ MCM
Arjohuntleigh AB
·
,
Sweden
Class IIa
CE/MDR
Alpha Active 4
Arjohuntleigh AB
·
,
Sweden
Class IIa
CE/MDR
PlasmaDerm Vario Universal, Model PlasmaDerm Flex
CINOGY GmbH
·
,
Germany
Class IIa
CE/MDR
Skin IQ MCM
Arjohuntleigh AB
·
,
Sweden
Class IIa
CE/MDR
Skin IQ MCM
Arjohuntleigh AB
·
,
Sweden
Class IIa
CE/MDR
Skin IQ MCM
Arjohuntleigh AB
·
,
Sweden
Class IIa
CE/MDR
Alpha Active 3
Arjohuntleigh AB
·
,
Sweden
Class IIa
CE/MDR
Tupferstab, Gaze / Gauze
REDA Instrumente GmbH
·
,
Germany
Class I
CE/MDR
AeroGuard ‘Jellyfish’
Medaxis AG
·
,
Switzerland
Class I
CE/MDR
GUDID
on market
Action
Naturelle Consumer Products
·
,
Northern Ireland
Class IIa
CE/MDR
GB26/00000012
Active
Valid to Feb 2031
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