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Prefilled syringes
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Prefilled syringes - other
Prefilled syringes - other
A02010799
70 devices
Prefilled syringe with purified water or glycerin solution
Well Lead Medical Co., Ltd
·
,
China
Class I
CE/MDR
Introx 2% (1 siringa preriempita)
Gruppo Farmaimpresa SRL
·
,
Italy
Class III
CE/MDR
×2
Active
CE/MDR
020-00-04-MDR
Withdrawn
Valid to Jun 2028
Prefilled syringe with purified water or glycerin solution
Well Lead Medical Co., Ltd
·
,
China
Class I
CE/MDR
D.B.M. C-Lock
Dbm SRL
·
,
Italy
Class IIb
CE/MDD
Introx 2% (3 siringhe preriempite)
Gruppo Farmaimpresa SRL
·
,
Italy
Class III
CE/MDR
×2
Active
CE/MDR
020-00-04-MDR
Withdrawn
Valid to Jun 2028
GO-ON Medical Device– Italy (HTL)
Rottapharm Ltd
·
,
Ireland
Class III
CE/MDD
Jesitrox 2% (1 siringa preriempita)
Gruppo Farmaimpresa SRL
·
,
Italy
Class III
CE/MDR
×2
Active
CE/MDR
020-00-04-MDR
Withdrawn
Valid to Jun 2028
HEALAVIS Classic 1%
Aptissen SA
·
,
Switzerland
Class III
CE/MDD
GO-ON Medical Device- Austria (HTL)
Rottapharm Ltd
·
,
Ireland
Class III
CE/MDD
Artox 1.6% (1 prefilled syringe)
Gruppo Farmaimpresa SRL
·
,
Italy
Class III
CE/MDR
×2
Active
CE/MDR
020-00-04-MDR
Withdrawn
Valid to Jun 2028
Ilatrox 2% (3 siringhe preriempite)
Gruppo Farmaimpresa SRL
·
,
Italy
Class III
CE/MDR
020-00-04-MDR
Withdrawn
Valid to Jun 2028
CE/MDR
×2
Active
Easy Fill Glycesure
Spm Medicare Pvt., Ltd.
·
,
India
Class I
CE/MDR
1000323461
Active
Valid to Aug 2029
Dexvur
Ekspo Farma İlaç Medi̇kal San. ve Ti̇c. Ltd. Şti̇.
·
,
Türkiye
Class III
CE/MDD
Healaflow
Aptissen SA
·
,
Switzerland
Class III
CE/MDD
Pre-filled Syringe
Hangzhou Primecare Medical Co., Ltd.
·
,
China
Class I
CE/MDR
GO-ON Medical Device– Belgian Market (Shiseido)
Rottapharm Ltd
·
,
Ireland
Class III
CE/MDD
GO-ON Medical Device– Portuguese Market (Shiseido)
Rottapharm Ltd
·
,
Ireland
Class III
CE/MDD
Synolis Va 40/80
Aptissen SA
·
,
Switzerland
Class III
CE/MDD
D.B.M. Aquagly
Dbm SRL
·
,
Italy
Class I
CE/MDR
0425-MDR-030159-00
Active
Valid to Nov 2030
Pre-filled Syringe
Hangzhou Primecare Medical Co., Ltd.
·
,
China
Class I
FDA 510(k)
K202698
Active
Cleared 15 Dec 2020
CE/MDR
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