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LithiX Hertz Contact Intravascular Lithotripsy Catheter

DAR1514

Class IIIMDR 2017/745On the marketSingle useSterile

Manufacturer: Elixir Medical Corporation
Manufacturer SRN: US-MF-000013041
UDI-DI: 00817508014978
Basic UDI-DI: 081750801LithiXY7
Reference: DAR1514
EMDN: C01040199
EMDN description: CARDIAC ANGIOGRAPHY DEVICES - OTHER
First on market country: Austria
Safety summary (SSCP/SSP): LBL00353 · Rev. Rev A
Authorised representative: Acorn Regulatory Consultancy Services Ltd
Last updated: 30.07.2026 19:58

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

OUTBACK Elite Re-Entry Catheter

Percutaneous Catheter - OUTBACK Elite Re-Entry Catheter

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Cordis US Corp.
Manufacturer SRN: US-MF-000020031
UDI-DI: 20705032067567
Basic UDI-DI: 07050320000000000000016CG
Reference: OTB59080A
EMDN: C0104020103
EMDN description: VASCULAR OCCLUSION CATHETERS
First on market country: Ireland
Authorised representative: Cordis Cashel
Last updated: 30.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

TEMPO™ Angiographic Catheter

Diagnostic Angiographic Catheter - TEMPO™

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Cordis US Corp.
Manufacturer SRN: US-MF-000020031
UDI-DI: 10705032048323
Basic UDI-DI: 07050320000000000000064CT
Reference: SRD5457
EMDN: C0104020101
EMDN description: PANORAMIC AND SELECTIVE PERIPHERAL DIAGNOSTIC ANGIOGRAPHY CATHETERS AND MICROCATHETERS
First on market country: Netherlands
Authorised representative: Cordis Cashel
Last updated: 30.07.2026 19:51

Manufacturer products Authorised representative products Authorised representative actors View details

IMPEDE-FX Embolization Plug, 6mm

IMPEDE Embolization Plug Product Family

Class IIIMDR 2017/745On the marketImplantableSingle useSterile

Manufacturer: Shape Memory Medical Inc
Manufacturer SRN: US-MF-000008157
UDI-DI: 00810041650030
Basic UDI-DI: 081004165IMP8Z
Reference: IMP-FX-06
EMDN: C010402020399
EMDN description: EMBOLISATION DEVICES - OTHER
First on market country: Spain
Safety summary (SSCP/SSP): SSCP-IMP-EN · Rev. C
Authorised representative: MedR-AR Services B.V.
Last updated: 30.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Anchor®

Anchor® SST Balloon Catheter Series

Class IIIMDR 2017/745On the marketSingle useSterile

Manufacturer: Dongguan TT Medical, Inc.
Manufacturer SRN: CN-MF-000039087
UDI-DI: 06934184045165
Basic UDI-DI: 069341840SSTLP
Reference: TT-PTCA-SST-BR-EN
EMDN: C010401020101
EMDN description: PTCA BALLOON DILATION CATHETERS
First on market country: Türkiye
Safety summary (SSCP/SSP): TT-PTCA-SSCP · Rev. 2.2
Authorised representative: Emergo Europe B.V.
Last updated: 30.07.2026 18:52

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Anchor®

Anchor® Ultra Balloon Catheter Series

Class IIIMDR 2017/745On the marketSingle useSterile

Manufacturer: Dongguan TT Medical, Inc.
Manufacturer SRN: CN-MF-000039087
UDI-DI: 06934184041549
Basic UDI-DI: 069341840USTLZ
Reference: TT-PTCA-UST-BR-EN
EMDN: C010401020101
EMDN description: PTCA BALLOON DILATION CATHETERS
First on market country: Türkiye
Safety summary (SSCP/SSP): TT-PTCA-SSCP · Rev. 2.2
Authorised representative: Emergo Europe B.V.
Last updated: 30.07.2026 18:51

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Anchor®

Anchor® DST Balloon Catheter Series

Class IIIMDR 2017/745On the marketSingle useSterile

Manufacturer: Dongguan TT Medical, Inc.
Manufacturer SRN: CN-MF-000039087
UDI-DI: 06934184041020
Basic UDI-DI: 069341840DSTJC
Reference: TT-PTCA-DST-BR-EN
EMDN: C010401020101
EMDN description: PTCA BALLOON DILATION CATHETERS
First on market country: Türkiye
Safety summary (SSCP/SSP): TT-PTCA-SSCP · Rev. 2.2
Authorised representative: Emergo Europe B.V.
Last updated: 30.07.2026 18:51

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

VesSpiral®

VesSpiral® Balloon Catheter Series

Class IIIMDR 2017/745On the marketSingle useSterile

Manufacturer: Dongguan TT Medical, Inc.
Manufacturer SRN: CN-MF-000039087
UDI-DI: 06934184041013
Basic UDI-DI: 069341840VSPLW
Reference: TT-PTCA-VSP-BR-EN
EMDN: C010401020101
EMDN description: PTCA BALLOON DILATION CATHETERS
First on market country: Türkiye
Safety summary (SSCP/SSP): TT-PTCA-SSCP · Rev. 2.2
Authorised representative: Emergo Europe B.V.
Last updated: 30.07.2026 18:51

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

VesPenetrator®

VesPenetrator Balloon Catheter Series

Class IIIMDR 2017/745On the marketSingle useSterile

Manufacturer: Dongguan TT Medical, Inc.
Manufacturer SRN: CN-MF-000039087
UDI-DI: 06934184036637
Basic UDI-DI: 069341840PDT6
Reference: TT-PTCA-PD-BR-EN
EMDN: C010401020101
EMDN description: PTCA BALLOON DILATION CATHETERS
First on market country: Türkiye
Safety summary (SSCP/SSP): TT-PTCA-SSCP · Rev. 2.2
Authorised representative: Emergo Europe B.V.
Last updated: 30.07.2026 18:51

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

VesTraveler®

VesTraveler® Balloon Catheter Series

Class IIIMDR 2017/745On the marketSingle useSterile

Manufacturer: Dongguan TT Medical, Inc.
Manufacturer SRN: CN-MF-000039087
UDI-DI: 06934184036347
Basic UDI-DI: 069341840SDTF
Reference: TT-PTCA-2SD-BR-EN
EMDN: C010401020101
EMDN description: PTCA BALLOON DILATION CATHETERS
First on market country: Türkiye
Safety summary (SSCP/SSP): TT-PTCA-SSCP · Rev. 2.2
Authorised representative: Emergo Europe B.V.
Last updated: 30.07.2026 18:51

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

VesTrek™

VesTrek™ HYB-C Balloon Catheter Series

Class IIIMDR 2017/745On the marketSingle useSterile

Manufacturer: Dongguan TT Medical, Inc.
Manufacturer SRN: CN-MF-000039087
UDI-DI: 06934184022746
Basic UDI-DI: 069341840HYBCCT
Reference: TT-PTCA-HYB-BR-EN
EMDN: C010401020101
EMDN description: PTCA BALLOON DILATION CATHETERS
First on market country: Türkiye
Safety summary (SSCP/SSP): TT-PTCA-SSCP · Rev. 2.2
Authorised representative: Emergo Europe B.V.
Last updated: 30.07.2026 18:51

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

VesTrek™

VesTrek™ HYB Balloon Catheter Series

Class IIIMDR 2017/745On the marketSingle useSterile

Manufacturer: Dongguan TT Medical, Inc.
Manufacturer SRN: CN-MF-000039087
UDI-DI: 06934184021558
Basic UDI-DI: 069341840HYBJE
Reference: TT-PTCA-HYB-BR-EN
EMDN: C010401020101
EMDN description: PTCA BALLOON DILATION CATHETERS
First on market country: Türkiye
Safety summary (SSCP/SSP): TT-PTCA-SSCP · Rev. 2.2
Authorised representative: Emergo Europe B.V.
Last updated: 30.07.2026 18:51

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

VesTrek™

VesTrek™ OTW Balloon Catheter Series

Class IIIMDR 2017/745On the marketSingle useSterile

Manufacturer: Dongguan TT Medical, Inc.
Manufacturer SRN: CN-MF-000039087
UDI-DI: 06934184018312
Basic UDI-DI: 069341840OTWLC
Reference: TT-PTCA-OTW-BR-EN
EMDN: C010401020101
EMDN description: PTCA BALLOON DILATION CATHETERS
First on market country: Türkiye
Safety summary (SSCP/SSP): TT-PTCA-SSCP · Rev. 2.2
Authorised representative: Emergo Europe B.V.
Last updated: 30.07.2026 18:51

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Anchor®

Anchor® Mini Balloon Catheter MCC Series

Class IIIMDR 2017/745On the marketSingle useSterile

Manufacturer: Dongguan TT Medical, Inc.
Manufacturer SRN: CN-MF-000039087
UDI-DI: 06934184018060
Basic UDI-DI: 069341840MCCH7
Reference: TT-PTCA-MBC-BR-EN
EMDN: C010401020101
EMDN description: PTCA BALLOON DILATION CATHETERS
First on market country: Türkiye
Safety summary (SSCP/SSP): TT-PTCA-SSCP · Rev. 2.2
Authorised representative: Emergo Europe B.V.
Last updated: 30.07.2026 18:51

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Anchor®

Anchor® Mini MBC Series

Class IIIMDR 2017/745On the marketSingle useSterile

Manufacturer: Dongguan TT Medical, Inc.
Manufacturer SRN: CN-MF-000039087
UDI-DI: 06934184017865
Basic UDI-DI: 069341840MBCH4
Reference: TT-PTCA-MBC-BR-EN
EMDN: C010401020101
EMDN description: PTCA BALLOON DILATION CATHETERS
First on market country: Türkiye
Safety summary (SSCP/SSP): TT-PTCA-SSCP · Rev. 2.2
Authorised representative: Emergo Europe B.V.
Last updated: 30.07.2026 18:51

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

VesSpiral®

VesSpiral® Ultra Balloon Catheter Series

Class IIIMDR 2017/745On the marketSingle useSterile

Manufacturer: Dongguan TT Medical, Inc.
Manufacturer SRN: CN-MF-000039087
UDI-DI: 06934184017094
Basic UDI-DI: 0693418403VSPAD
Reference: TT-PTCA-3VSP-BR-EN
EMDN: C010401020101
EMDN description: PTCA BALLOON DILATION CATHETERS
First on market country: Türkiye
Safety summary (SSCP/SSP): TT-PTCA-SSCP · Rev. 2.2
Authorised representative: Emergo Europe B.V.
Last updated: 30.07.2026 18:51

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

VexPander®

VexPander® Balloon Catheter Series

Class IIIMDR 2017/745On the marketSingle useSterile

Manufacturer: Dongguan TT Medical, Inc.
Manufacturer SRN: CN-MF-000039087
UDI-DI: 06934184011184
Basic UDI-DI: 069341840NCSW
Reference: TT-PTCA-2NC-BR-EN
EMDN: C010401020101
EMDN description: PTCA BALLOON DILATION CATHETERS
First on market country: Türkiye
Safety summary (SSCP/SSP): TT-PTCA-SSCP · Rev. 2.2
Authorised representative: Emergo Europe B.V.
Last updated: 30.07.2026 18:51

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

PiCSO Impulse ECG Cable, AHA

PiCSO Impulse ECG Cable

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Miracor Medical SA
Manufacturer SRN: BE-MF-000001089
UDI-DI: 05430002982120
Basic UDI-DI: 05430002982103X000VL
Reference: 1.03.1000
EMDN: C01040180
EMDN description: CORONARY ANGIOGRAPHY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 18:49

Manufacturer products View details

+B828109020001

MedNet Radial Compression Device

Class IMDR 2017/745On the marketSingle use

Manufacturer: MedNet GmbH
Manufacturer SRN: DE-MF-000006253
UDI-DI: +B828109020001
Basic UDI-DI: ++B82811910H7
Reference: 10902000
EMDN: C01040180
EMDN description: CORONARY ANGIOGRAPHY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 18:13

Manufacturer products View details

ARES

ARES - BID6002 - İndeflatör

Class IMDDOn the marketSingle useSterile

Manufacturer: Ares Medikal Sanayi Ticaret Ltd. Şti.
Manufacturer SRN: TR-MF-000029015
UDI-DI: 86989077437806
Basic UDI-DI: B-86989077437806
Reference: ARES - BID6002
EMDN: C010401020180
EMDN description: PTCA BALLOON DILATATION CATHETERS - ACCESSORIES
First on market country: Türkiye
Authorised representative: -
Last updated: 30.07.2026 18:08

Manufacturer products View details