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Syringes
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Single-use syringes
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Prefilled syringes
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Prefilled syringes - other
Prefilled syringes - other
A02010799
70 devices
Devices
GO-ON Medical Device – German Market (Shiseido)
Rottapharm Ltd
·
,
IE
Class III
CE/MDD
Synolis Va 80/160
Aptissen SA
·
,
CH
Class III
CE/MDD
Artox 1.6% (3 prefilled syringes)
Gruppo Farmaimpresa SRL
·
,
IT
Class III
CE/MDR
009-00-21-MDR
Active
Valid to Jan 2028
CE/MDR
020-00-04-MDR
Withdrawn
Valid to Jun 2028
+1
authorizations
Jesitrox 2% (3 siringhe preriempite)
Gruppo Farmaimpresa SRL
·
,
IT
Class III
CE/MDR
020-00-04-MDR
Withdrawn
Valid to Jun 2028
CE/MDR
009-00-21-MDR
Active
Valid to Jan 2028
+1
authorizations
Leovisc 2% (1 siringa preriempita)
Gruppo Farmaimpresa SRL
·
,
IT
Class III
CE/MDR
009-00-21-MDR
Active
Valid to Jan 2028
CE/MDR
020-00-04-MDR
Withdrawn
Valid to Jun 2028
+1
authorizations
GO-ON Medical Device– Baltic Markets (Estonia, Lithuania, Latvia) (HTL)
Rottapharm Ltd
·
,
IE
Class III
CE/MDD
CitraFlow
MedXL Inc
·
,
CA
Class IIa
CE/MDD
GO-ON Medical Device– Baltic Markets (Estonia, Lithuania, Latvia) - Shiseido
Rottapharm Ltd
·
,
IE
Class III
CE/MDD
Artox 2% (3 prefilled syringes)
Gruppo Farmaimpresa SRL
·
,
IT
Class III
CE/MDR
009-00-21-MDR
Active
Valid to Jan 2028
CE/MDR
020-00-04-MDR
Withdrawn
Valid to Jun 2028
+1
authorizations
Ilatrox 2% (1 siringa preriempita)
Gruppo Farmaimpresa SRL
·
,
IT
Class III
CE/MDR
021-00-06-MDR
Active
Valid to Jun 2028
CE/MDR
009-00-21-MDR
Active
Valid to Jan 2028
+1
authorizations
Artox 2% (1 prefilled syringe)
Gruppo Farmaimpresa SRL
·
,
IT
Class III
CE/MDR
009-00-21-MDR
Active
Valid to Jan 2028
CE/MDR
020-00-04-MDR
Withdrawn
Valid to Jun 2028
+1
authorizations
GO-ON Medical Device– French Market (Shiseido)
Rottapharm Ltd
·
,
IE
Class III
CE/MDD
Pre-filled Syringe
Hangzhou Primecare Medical Co., Ltd.
·
,
CN
Class I
CE/MDR
Citraflow
MedXL Inc
·
,
CA
Class IIa
CE/MDD
Dexsui
Ekspo Farma İlaç Medi̇kal San. ve Ti̇c. Ltd. Şti̇.
·
,
TR
Class III
CE/MDD
Siringa Gel Lubrificante
Betatex SpA
·
,
IT
Class IIb
CE/MDR
CitraFlow
MedXL Inc
·
,
CA
Class IIa
CE/MDD
GO-ON Medical Device– Spanish Market (Shiseido)
Rottapharm Ltd
·
,
IE
Class III
CE/MDD
GO-ON Medical Device– French Market (HTL)
Rottapharm Ltd
·
,
IE
Class III
CE/MDD
GO-ON Medical Device– Belgian Market (HTL)
Rottapharm Ltd
·
,
IE
Class III
CE/MDD
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