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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

Last updated

25.09.2026 14:54

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Active filter:EMDN:H010101010104

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MONOFIX PDO

Absorbable Knotless Wound Closure Device

Class IIIMDR 2017/745On the marketImplantableSingle useSterile
Manufacturer
Samyang Biopharm Corporation
Manufacturer SRN
KR-MF-000037085
UDI-DI
08809766323123
Basic UDI-DI
880936647KM01MT
Reference
KM1115S
EMDN
H010101010104
EMDN description
MOUNTED POLYDIOXANONE MONOFILAMENT WITH NEEDLE FOR TISSUE TRACTION (‘BARBED’)
First on market country
Netherlands
Safety summary (SSCP/SSP)
SSCP-MKM-01 · Rev. 5
Authorised representative
Samyang Biopharm Magyarország Kft.
Last updated
23.09.2026 14:34
Class IIIMDR 2017/745On the marketImplantableSingle useSterile
Manufacturer
Samyang Biopharm Corporation
Manufacturer SRN
KR-MF-000037085
UDI-DI
08809766323147
Basic UDI-DI
880936647KM01MT
Reference
KM1125S
EMDN
H010101010104
EMDN description
MOUNTED POLYDIOXANONE MONOFILAMENT WITH NEEDLE FOR TISSUE TRACTION (‘BARBED’)
First on market country
-
Safety summary (SSCP/SSP)
SSCP-MKM-01 · Rev. 5
Authorised representative
Samyang Biopharm Magyarország Kft.
Last updated
23.09.2026 00:24
Class IIIMDR 2017/745On the marketImplantableSingle useSterile
Manufacturer
Samyang Biopharm Corporation
Manufacturer SRN
KR-MF-000037085
UDI-DI
08809766323161
Basic UDI-DI
880936647KM01MT
Reference
KM1145S
EMDN
H010101010104
EMDN description
MOUNTED POLYDIOXANONE MONOFILAMENT WITH NEEDLE FOR TISSUE TRACTION (‘BARBED’)
First on market country
-
Safety summary (SSCP/SSP)
SSCP-MKM-01 · Rev. 5
Authorised representative
Samyang Biopharm Magyarország Kft.
Last updated
23.09.2026 00:24
Class IIIMDR 2017/745On the marketImplantableSingle useSterile
Manufacturer
Samyang Biopharm Corporation
Manufacturer SRN
KR-MF-000037085
UDI-DI
08809766323185
Basic UDI-DI
880936647KM01MT
Reference
KM1165S
EMDN
H010101010104
EMDN description
MOUNTED POLYDIOXANONE MONOFILAMENT WITH NEEDLE FOR TISSUE TRACTION (‘BARBED’)
First on market country
-
Safety summary (SSCP/SSP)
SSCP-MKM-01 · Rev. 5
Authorised representative
Samyang Biopharm Magyarország Kft.
Last updated
23.09.2026 00:24
Class IIIMDR 2017/745On the marketImplantableSingle useSterile
Manufacturer
Samyang Biopharm Corporation
Manufacturer SRN
KR-MF-000037085
UDI-DI
08809766323208
Basic UDI-DI
880936647KM01MT
Reference
KM1411S
EMDN
H010101010104
EMDN description
MOUNTED POLYDIOXANONE MONOFILAMENT WITH NEEDLE FOR TISSUE TRACTION (‘BARBED’)
First on market country
-
Safety summary (SSCP/SSP)
SSCP-MKM-01 · Rev. 5
Authorised representative
Samyang Biopharm Magyarország Kft.
Last updated
23.09.2026 00:24
Class IIIMDR 2017/745On the marketImplantableSingle useSterile
Manufacturer
Samyang Biopharm Corporation
Manufacturer SRN
KR-MF-000037085
UDI-DI
08809766323222
Basic UDI-DI
880936647KM01MT
Reference
KM1422S
EMDN
H010101010104
EMDN description
MOUNTED POLYDIOXANONE MONOFILAMENT WITH NEEDLE FOR TISSUE TRACTION (‘BARBED’)
First on market country
-
Safety summary (SSCP/SSP)
SSCP-MKM-01 · Rev. 5
Authorised representative
Samyang Biopharm Magyarország Kft.
Last updated
23.09.2026 00:24
Barb-E

Monofilament Poly(p-dioxanone) Barbed Suture with needle (Violet)

Class IIIMDR 2017/745On the marketImplantableSingle useSterile
Manufacturer
TI Medical Private Limited
Manufacturer SRN
IN-MF-000026561
UDI-DI
08904248242357
Basic UDI-DI
89042482BAR011D4
Reference
TI/C-BRO/01
EMDN
H010101010104
EMDN description
MOUNTED POLYDIOXANONE MONOFILAMENT WITH NEEDLE FOR TISSUE TRACTION (‘BARBED’)
First on market country
Germany
Safety summary (SSCP/SSP)
RA/SOP/08/F01-04 · Rev. 03
Authorised representative
Obelis s.a.
Last updated
22.09.2026 22:16
Class IIIMDR 2017/745On the marketImplantableSingle useSterile
Manufacturer
TI Medical Private Limited
Manufacturer SRN
IN-MF-000026561
UDI-DI
08904248296046
Basic UDI-DI
89042482BAR011D4
Reference
TI/C-BRO/01
EMDN
H010101010104
EMDN description
MOUNTED POLYDIOXANONE MONOFILAMENT WITH NEEDLE FOR TISSUE TRACTION (‘BARBED’)
First on market country
-
Safety summary (SSCP/SSP)
RA/SOP/08/F01-04 · Rev. 03
Authorised representative
Obelis s.a.
Last updated
22.09.2026 21:56
Class IIIMDR 2017/745On the marketImplantableSingle useSterile
Manufacturer
TI Medical Private Limited
Manufacturer SRN
IN-MF-000026561
UDI-DI
08904248264144
Basic UDI-DI
89042482BAR011D4
Reference
TI/C-BRO/01
EMDN
H010101010104
EMDN description
MOUNTED POLYDIOXANONE MONOFILAMENT WITH NEEDLE FOR TISSUE TRACTION (‘BARBED’)
First on market country
-
Safety summary (SSCP/SSP)
RA/SOP/08/F01-04 · Rev. 03
Authorised representative
Obelis s.a.
Last updated
22.09.2026 21:56
Class IIIMDR 2017/745On the marketImplantableSingle useSterile
Manufacturer
TI Medical Private Limited
Manufacturer SRN
IN-MF-000026561
UDI-DI
08904248296015
Basic UDI-DI
89042482BAR011D4
Reference
TI/C-BRO/01
EMDN
H010101010104
EMDN description
MOUNTED POLYDIOXANONE MONOFILAMENT WITH NEEDLE FOR TISSUE TRACTION (‘BARBED’)
First on market country
-
Safety summary (SSCP/SSP)
RA/SOP/08/F01-04 · Rev. 03
Authorised representative
Obelis s.a.
Last updated
22.09.2026 21:56
Class IIIMDR 2017/745On the marketImplantableSingle useSterile
Manufacturer
TI Medical Private Limited
Manufacturer SRN
IN-MF-000026561
UDI-DI
08904248296039
Basic UDI-DI
89042482BAR011D4
Reference
TI/C-BRO/01
EMDN
H010101010104
EMDN description
MOUNTED POLYDIOXANONE MONOFILAMENT WITH NEEDLE FOR TISSUE TRACTION (‘BARBED’)
First on market country
-
Safety summary (SSCP/SSP)
RA/SOP/08/F01-04 · Rev. 03
Authorised representative
Obelis s.a.
Last updated
22.09.2026 21:56
Class IIIMDR 2017/745On the marketImplantableSingle useSterile
Manufacturer
TI Medical Private Limited
Manufacturer SRN
IN-MF-000026561
UDI-DI
08904248290037
Basic UDI-DI
89042482BAR011D4
Reference
TI/C-BRO/01
EMDN
H010101010104
EMDN description
MOUNTED POLYDIOXANONE MONOFILAMENT WITH NEEDLE FOR TISSUE TRACTION (‘BARBED’)
First on market country
-
Safety summary (SSCP/SSP)
RA/SOP/08/F01-04 · Rev. 03
Authorised representative
Obelis s.a.
Last updated
22.09.2026 21:55
Class IIIMDR 2017/745On the marketImplantableSingle useSterile
Manufacturer
TI Medical Private Limited
Manufacturer SRN
IN-MF-000026561
UDI-DI
08904248295995
Basic UDI-DI
89042482BAR011D4
Reference
TI/C-BRO/01
EMDN
H010101010104
EMDN description
MOUNTED POLYDIOXANONE MONOFILAMENT WITH NEEDLE FOR TISSUE TRACTION (‘BARBED’)
First on market country
-
Safety summary (SSCP/SSP)
RA/SOP/08/F01-04 · Rev. 03
Authorised representative
Obelis s.a.
Last updated
22.09.2026 21:55
Class IIIMDR 2017/745On the marketImplantableSingle useSterile
Manufacturer
TI Medical Private Limited
Manufacturer SRN
IN-MF-000026561
UDI-DI
08904248292123
Basic UDI-DI
89042482BAR011D4
Reference
TI/C-BRO/01
EMDN
H010101010104
EMDN description
MOUNTED POLYDIOXANONE MONOFILAMENT WITH NEEDLE FOR TISSUE TRACTION (‘BARBED’)
First on market country
-
Safety summary (SSCP/SSP)
RA/SOP/08/F01-04 · Rev. 03
Authorised representative
Obelis s.a.
Last updated
22.09.2026 21:55
Class IIIMDR 2017/745On the marketImplantableSingle useSterile
Manufacturer
TI Medical Private Limited
Manufacturer SRN
IN-MF-000026561
UDI-DI
08904248268135
Basic UDI-DI
89042482BAR011D4
Reference
TI/C-BRO/01
EMDN
H010101010104
EMDN description
MOUNTED POLYDIOXANONE MONOFILAMENT WITH NEEDLE FOR TISSUE TRACTION (‘BARBED’)
First on market country
-
Safety summary (SSCP/SSP)
RA/SOP/08/F01-04 · Rev. 03
Authorised representative
Obelis s.a.
Last updated
22.09.2026 21:55
Class IIIMDR 2017/745On the marketImplantableSingle useSterile
Manufacturer
TI Medical Private Limited
Manufacturer SRN
IN-MF-000026561
UDI-DI
08904248292116
Basic UDI-DI
89042482BAR011D4
Reference
TI/C-BRO/01
EMDN
H010101010104
EMDN description
MOUNTED POLYDIOXANONE MONOFILAMENT WITH NEEDLE FOR TISSUE TRACTION (‘BARBED’)
First on market country
-
Safety summary (SSCP/SSP)
RA/SOP/08/F01-04 · Rev. 03
Authorised representative
Obelis s.a.
Last updated
22.09.2026 21:55
Class IIIMDR 2017/745On the marketImplantableSingle useSterile
Manufacturer
TI Medical Private Limited
Manufacturer SRN
IN-MF-000026561
UDI-DI
08904248292109
Basic UDI-DI
89042482BAR011D4
Reference
TI/C-BRO/01
EMDN
H010101010104
EMDN description
MOUNTED POLYDIOXANONE MONOFILAMENT WITH NEEDLE FOR TISSUE TRACTION (‘BARBED’)
First on market country
-
Safety summary (SSCP/SSP)
RA/SOP/08/F01-04 · Rev. 03
Authorised representative
Obelis s.a.
Last updated
22.09.2026 21:55
Class IIIMDR 2017/745On the marketImplantableSingle useSterile
Manufacturer
TI Medical Private Limited
Manufacturer SRN
IN-MF-000026561
UDI-DI
08909296008511
Basic UDI-DI
89042482BAR011D4
Reference
TI/C-BRO/01
EMDN
H010101010104
EMDN description
MOUNTED POLYDIOXANONE MONOFILAMENT WITH NEEDLE FOR TISSUE TRACTION (‘BARBED’)
First on market country
-
Safety summary (SSCP/SSP)
RA/SOP/08/F01-04 · Rev. 03
Authorised representative
Obelis s.a.
Last updated
22.09.2026 21:55
Class IIIMDR 2017/745On the marketImplantableSingle useSterile
Manufacturer
TI Medical Private Limited
Manufacturer SRN
IN-MF-000026561
UDI-DI
08904248296008
Basic UDI-DI
89042482BAR011D4
Reference
TI/C-BRO/01
EMDN
H010101010104
EMDN description
MOUNTED POLYDIOXANONE MONOFILAMENT WITH NEEDLE FOR TISSUE TRACTION (‘BARBED’)
First on market country
-
Safety summary (SSCP/SSP)
RA/SOP/08/F01-04 · Rev. 03
Authorised representative
Obelis s.a.
Last updated
22.09.2026 21:55
Class IIIMDR 2017/745On the marketImplantableSingle useSterile
Manufacturer
TI Medical Private Limited
Manufacturer SRN
IN-MF-000026561
UDI-DI
08904248281554
Basic UDI-DI
89042482BAR011D4
Reference
TI/C-BRO/01
EMDN
H010101010104
EMDN description
MOUNTED POLYDIOXANONE MONOFILAMENT WITH NEEDLE FOR TISSUE TRACTION (‘BARBED’)
First on market country
-
Safety summary (SSCP/SSP)
RA/SOP/08/F01-04 · Rev. 03
Authorised representative
Obelis s.a.
Last updated
22.09.2026 21:55