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GEM Microvascular Anastomic COUPLER

MICROVASCULAR ANASTOMOTIC COUPLER DEVICE

Class IIbMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Synovis Micro Companies Alliance, Inc. (a subsidiary of Baxter International Inc.)
Manufacturer SRN
US-MF-000034162
UDI-DI
00844735006391
Basic UDI-DI
478180000000000000001157R
Reference
GEM2750/I
EMDN
P07010299
EMDN description
VASCULAR PROSTHESES, SYNTHETIC - OTHER
First on market country
Germany
Safety summary (SSCP/SSP)
BXU574608_MDR_SSCP · Rev. D
Authorised representative
Baxter Deutschland GmbH
Last updated
16.07.2026 09:34
Class IIbNot specifiedOn the marketImplantableSingle useSterile
Manufacturer
Biovic Sdn Bhd
Manufacturer SRN
MY-MF-000013727
UDI-DI
09555952300445
Basic UDI-DI
955595230PVGV9
Reference
PVGRG0420
EMDN
P070102020101
EMDN description
PTFE VASCULAR PROSTHESES, STRAIGHT, SIMPLE
First on market country
-
Safety summary (SSCP/SSP)
PTFE-VG-056 · Rev. 001
Authorised representative
Advena Limited
Last updated
13.07.2026 23:14
Class IIbNot specifiedOn the marketImplantableSingle useSterile
Manufacturer
Biovic Sdn Bhd
Manufacturer SRN
MY-MF-000013727
UDI-DI
09555952300124
Basic UDI-DI
955595230PVGV9
Reference
PVGRG0660
EMDN
P070102020101
EMDN description
PTFE VASCULAR PROSTHESES, STRAIGHT, SIMPLE
First on market country
-
Safety summary (SSCP/SSP)
PTFE-VG-056 · Rev. 001
Authorised representative
Advena Limited
Last updated
13.07.2026 06:45
Class IIbNot specifiedOn the marketImplantableSingle useSterile
Manufacturer
Biovic Sdn Bhd
Manufacturer SRN
MY-MF-000013727
UDI-DI
09555952300117
Basic UDI-DI
955595230PVGV9
Reference
PVGRG0645
EMDN
P070102020101
EMDN description
PTFE VASCULAR PROSTHESES, STRAIGHT, SIMPLE
First on market country
-
Safety summary (SSCP/SSP)
PTFE-VG-056 · Rev. 001
Authorised representative
Advena Limited
Last updated
13.07.2026 06:45
Class IIbNot specifiedOn the marketImplantableSingle useSterile
Manufacturer
Biovic Sdn Bhd
Manufacturer SRN
MY-MF-000013727
UDI-DI
09555952300094
Basic UDI-DI
955595230PVGV9
Reference
PVGRG0620
EMDN
P070102020101
EMDN description
PTFE VASCULAR PROSTHESES, STRAIGHT, SIMPLE
First on market country
-
Safety summary (SSCP/SSP)
PTFE-VG-056 · Rev. 001
Authorised representative
Advena Limited
Last updated
13.07.2026 06:45
Class IIbNot specifiedOn the marketImplantableSingle useSterile
Manufacturer
Biovic Sdn Bhd
Manufacturer SRN
MY-MF-000013727
UDI-DI
09555952300537
Basic UDI-DI
955595230PVGV9
Reference
PVGRG0575
EMDN
P070102020101
EMDN description
PTFE VASCULAR PROSTHESES, STRAIGHT, SIMPLE
First on market country
-
Safety summary (SSCP/SSP)
PTFE-VG-056 · Rev. 001
Authorised representative
Advena Limited
Last updated
13.07.2026 06:45
Class IIbNot specifiedOn the marketImplantableSingle useSterile
Manufacturer
Biovic Sdn Bhd
Manufacturer SRN
MY-MF-000013727
UDI-DI
09555952300070
Basic UDI-DI
955595230PVGV9
Reference
PVGRG0560
EMDN
P070102020101
EMDN description
PTFE VASCULAR PROSTHESES, STRAIGHT, SIMPLE
First on market country
-
Safety summary (SSCP/SSP)
PTFE-VG-056 · Rev. 001
Authorised representative
Advena Limited
Last updated
13.07.2026 06:45
Class IIbNot specifiedOn the marketImplantableSingle useSterile
Manufacturer
Biovic Sdn Bhd
Manufacturer SRN
MY-MF-000013727
UDI-DI
09555952300063
Basic UDI-DI
955595230PVGV9
Reference
PVGRG0545
EMDN
P070102020101
EMDN description
PTFE VASCULAR PROSTHESES, STRAIGHT, SIMPLE
First on market country
-
Safety summary (SSCP/SSP)
PTFE-VG-056 · Rev. 001
Authorised representative
Advena Limited
Last updated
13.07.2026 06:45
Class IIbNot specifiedOn the marketImplantableSingle useSterile
Manufacturer
Biovic Sdn Bhd
Manufacturer SRN
MY-MF-000013727
UDI-DI
09555952300049
Basic UDI-DI
955595230PVGV9
Reference
PVGRG0520
EMDN
P070102020101
EMDN description
PTFE VASCULAR PROSTHESES, STRAIGHT, SIMPLE
First on market country
-
Safety summary (SSCP/SSP)
PTFE-VG-056 · Rev. 001
Authorised representative
Advena Limited
Last updated
13.07.2026 06:45
Pletená cévní protéza s kolagenem Ra K

1. Knitted vascular prosthesis with collagen Ra lv K. 2. Knitted vascular prosthesis with collagen Ra bv K. 3. Knitted vascular prosthesis with collagen Ra K incompressible.

Class IIIMDDOn the marketAnimal tissuesImplantableSingle useSterile
Manufacturer
VUP Medical, a.s.
Manufacturer SRN
CZ-MF-000042015
UDI-DI
D-8591954RAKMVAV
Basic UDI-DI
B-8591954RAKMVAV
Reference
-
EMDN
P070102010101
EMDN description
DACRON VASCULAR PROSTHESES, STRAIGHT, KNITTED
First on market country
Czechia
Authorised representative
-
Last updated
12.07.2026 10:19
Class IIbNot specifiedOn the marketImplantableSingle useSterile
Manufacturer
Biovic Sdn Bhd
Manufacturer SRN
MY-MF-000013727
UDI-DI
09555952300629
Basic UDI-DI
955595230PVGV9
Reference
PVGFH0775
EMDN
P070102020101
EMDN description
PTFE VASCULAR PROSTHESES, STRAIGHT, SIMPLE
First on market country
-
Safety summary (SSCP/SSP)
PTFE-VG-056 · Rev. 001
Authorised representative
Advena Limited
Last updated
10.07.2026 22:58
Class IIbNot specifiedOn the marketImplantableSingle useSterile
Manufacturer
Biovic Sdn Bhd
Manufacturer SRN
MY-MF-000013727
UDI-DI
09555952300520
Basic UDI-DI
955595230PVGV9
Reference
PVGFH0760
EMDN
P070102020101
EMDN description
PTFE VASCULAR PROSTHESES, STRAIGHT, SIMPLE
First on market country
-
Safety summary (SSCP/SSP)
PTFE-VG-056 · Rev. 001
Authorised representative
Advena Limited
Last updated
10.07.2026 22:58
Class IIbNot specifiedOn the marketImplantableSingle useSterile
Manufacturer
Biovic Sdn Bhd
Manufacturer SRN
MY-MF-000013727
UDI-DI
09555952300582
Basic UDI-DI
955595230PVGV9
Reference
PVGFH0720
EMDN
P070102020101
EMDN description
PTFE VASCULAR PROSTHESES, STRAIGHT, SIMPLE
First on market country
-
Safety summary (SSCP/SSP)
PTFE-VG-056 · Rev. 001
Authorised representative
Advena Limited
Last updated
10.07.2026 22:58
Class IIbNot specifiedOn the marketImplantableSingle useSterile
Manufacturer
Biovic Sdn Bhd
Manufacturer SRN
MY-MF-000013727
UDI-DI
09555952300513
Basic UDI-DI
955595230PVGV9
Reference
PVGFH0745
EMDN
P070102020101
EMDN description
PTFE VASCULAR PROSTHESES, STRAIGHT, SIMPLE
First on market country
-
Safety summary (SSCP/SSP)
PTFE-VG-056 · Rev. 001
Authorised representative
Advena Limited
Last updated
10.07.2026 22:58
Class IIbNot specifiedOn the marketImplantableSingle useSterile
Manufacturer
Biovic Sdn Bhd
Manufacturer SRN
MY-MF-000013727
UDI-DI
09555952300612
Basic UDI-DI
955595230PVGV9
Reference
PVGFH0675
EMDN
P070102020101
EMDN description
PTFE VASCULAR PROSTHESES, STRAIGHT, SIMPLE
First on market country
-
Safety summary (SSCP/SSP)
PTFE-VG-056 · Rev. 001
Authorised representative
Advena Limited
Last updated
10.07.2026 22:58
Class IIbNot specifiedOn the marketImplantableSingle useSterile
Manufacturer
Biovic Sdn Bhd
Manufacturer SRN
MY-MF-000013727
UDI-DI
09555952300292
Basic UDI-DI
955595230PVGV9
Reference
PVGFH0660
EMDN
P070102020101
EMDN description
PTFE VASCULAR PROSTHESES, STRAIGHT, SIMPLE
First on market country
-
Safety summary (SSCP/SSP)
PTFE-VG-056 · Rev. 001
Authorised representative
Advena Limited
Last updated
10.07.2026 22:58
Class IIbNot specifiedOn the marketImplantableSingle useSterile
Manufacturer
Biovic Sdn Bhd
Manufacturer SRN
MY-MF-000013727
UDI-DI
09555952300285
Basic UDI-DI
955595230PVGV9
Reference
PVGFH0645
EMDN
P070102020101
EMDN description
PTFE VASCULAR PROSTHESES, STRAIGHT, SIMPLE
First on market country
-
Safety summary (SSCP/SSP)
PTFE-VG-056 · Rev. 001
Authorised representative
Advena Limited
Last updated
10.07.2026 22:58
Class IIbNot specifiedOn the marketImplantableSingle useSterile
Manufacturer
Biovic Sdn Bhd
Manufacturer SRN
MY-MF-000013727
UDI-DI
09555952300575
Basic UDI-DI
955595230PVGV9
Reference
PVGFH0620
EMDN
P070102020101
EMDN description
PTFE VASCULAR PROSTHESES, STRAIGHT, SIMPLE
First on market country
-
Safety summary (SSCP/SSP)
PTFE-VG-056 · Rev. 001
Authorised representative
Advena Limited
Last updated
10.07.2026 22:56
Class IIbNot specifiedOn the marketImplantableSingle useSterile
Manufacturer
Biovic Sdn Bhd
Manufacturer SRN
MY-MF-000013727
UDI-DI
09555952300605
Basic UDI-DI
955595230PVGV9
Reference
PVGFH0575
EMDN
P070102020101
EMDN description
PTFE VASCULAR PROSTHESES, STRAIGHT, SIMPLE
First on market country
-
Safety summary (SSCP/SSP)
PTFE-VG-056 · Rev. 001
Authorised representative
Advena Limited
Last updated
10.07.2026 22:56
Class IIbNot specifiedOn the marketImplantableSingle useSterile
Manufacturer
Biovic Sdn Bhd
Manufacturer SRN
MY-MF-000013727
UDI-DI
09555952300254
Basic UDI-DI
955595230PVGV9
Reference
PVGFH0560
EMDN
P070102020101
EMDN description
PTFE VASCULAR PROSTHESES, STRAIGHT, SIMPLE
First on market country
-
Safety summary (SSCP/SSP)
PTFE-VG-056 · Rev. 001
Authorised representative
Advena Limited
Last updated
10.07.2026 22:56