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Digital Indeflator INFLANTE

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Telemedicina, UAB
Manufacturer SRN: LT-MF-000038144
UDI-DI: 04779058100104
Basic UDI-DI: 477905810INFLANTE9F
Reference: IND01
EMDN: C01040280
EMDN description: PERIPHERAL ANGIOGRAPHY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES
First on market country: Lithuania
Authorised representative: -
Last updated: 31.07.2026 07:08

Manufacturer products View details

Tokai Microcatheter, Carnelian Support BTA

Tokai Microcatheter

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Tokai Medical Products, Inc.
Manufacturer SRN: JP-MF-000011106
UDI-DI: 04562382432160
Basic UDI-DI: 456238243MPUK
Reference: MCPB150-E
EMDN: C0104020205
EMDN description: PHARMACEUTICAL INFUSION AND ADMINISTRATION INTRAVASCULAR CATHETERS AND MICROCATHETERS
First on market country: Sweden
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 06:01

Manufacturer products Authorised representative products Authorised representative actors View details

Tokai Microcatheter, Carnelian 2.2

Tokai Microcatheter

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Tokai Medical Products, Inc.
Manufacturer SRN: JP-MF-000011106
UDI-DI: 04562382431866
Basic UDI-DI: 456238243MCTR
Reference: MCV110S-E
EMDN: C0104020202
EMDN description: PERIPHERAL EMBOLISATION CATHETERS AND MICROCATHETERS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 06:01

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SASUKE

SASUKE Double Lumen Catheter (RX/OTW)

Class IIIMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: ASAHI INTECC CO., LTD.
Manufacturer SRN: JP-MF-000010199
UDI-DI: 04547327120180
Basic UDI-DI: 4547327ADC016GQ
Reference: SA145-33N
EMDN: C0104010203
EMDN description: PHARMACEUTICAL INFUSION AND ADMINISTRATION INTRACORONARY AND INTRACARDIAC CATHETERS
First on market country: Austria
Safety summary (SSCP/SSP): AMM-C2511 · Rev. 1
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 05:53

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

Corsair Pro XS

Corsair Pro XS Microcatheter

Class IIIMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: ASAHI INTECC CO., LTD.
Manufacturer SRN: JP-MF-000010199
UDI-DI: 04547327137829
Basic UDI-DI: 4547327AMC021KL
Reference: CSR135-21S
EMDN: C0104010203
EMDN description: PHARMACEUTICAL INFUSION AND ADMINISTRATION INTRACORONARY AND INTRACARDIAC CATHETERS
First on market country: Austria
Safety summary (SSCP/SSP): AMM-C3111 · Rev. ０
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 05:53

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

Masters PARKWAY SOFT

Masters PARKWAY HF Microcatheter, Masters PARKWAY SOFT Microcatheter, ASAHI Veloute Microcatheter, ASAHI Tellus Microcatheter

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: ASAHI INTECC CO., LTD.
Manufacturer SRN: JP-MF-000010199
UDI-DI: 04547327086349
Basic UDI-DI: 4547327BMC009LB
Reference: WMST105-18PWSF
EMDN: C0104020202
EMDN description: PERIPHERAL EMBOLISATION CATHETERS AND MICROCATHETERS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 05:53

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Aperta NSE PTA Balloon Dilatation Catheter

Balloon length 40mm x Catheter length 50cm, 90cm, 145cm

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: NIPRO VASCULAR CORPORATION
Manufacturer SRN: JP-MF-000001989
UDI-DI: 04543660025595
Basic UDI-DI: 4543660GMW172A100000000YC
Reference: AA18-05040040
EMDN: C010402020101
EMDN description: PTA BALLOON DILATATION CATHETERS
First on market country: Italy
Authorised representative: Nipro Vascular Ireland Ltd
Last updated: 31.07.2026 05:52

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pRESET STANDARD Thrombectomy Device

Thrombectomy Systems

Class IIIMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: phenox GmbH
Manufacturer SRN: DE-MF-000006524
UDI-DI: 04260123784058
Basic UDI-DI: 426012378ThrombectomyF6
Reference: PRE-4-20
EMDN: C010402020702
EMDN description: MECHANICAL PERIPHERAL THROMBECTOMY AND THROMBOASPIRATION SYSTEMS
First on market country: Germany
Safety summary (SSCP/SSP): 67.30.001_SSCP-THROMBECTOMY SYSTEMS · Rev. D
Authorised representative: -
Last updated: 31.07.2026 01:31

Manufacturer products Open in EUDAMED View details

Calbreak

Coronary Cutting Balloon Dilatation Catheter

Class IIIMDR 2017/745On the marketSingle useSterile

Manufacturer: SWL Medizin GmbH
Manufacturer SRN: DE-MF-000008000
UDI-DI: 04251790255194
Basic UDI-DI: 42517902VBCVE
Reference: 835519
EMDN: C010401020101
EMDN description: PTCA BALLOON DILATION CATHETERS
First on market country: Türkiye
Safety summary (SSCP/SSP): SWL-SSCP-VBC-001 · Rev. 2
Authorised representative: -
Last updated: 31.07.2026 01:07

Manufacturer products Open in EUDAMED View details

Mercury

PTA Balloon Dilatation Catheter

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: SWL Medizin GmbH
Manufacturer SRN: DE-MF-000008000
UDI-DI: 04251790213743
Basic UDI-DI: 42517902POTWQW
Reference: POTW831374
EMDN: C010402020101
EMDN description: PTA BALLOON DILATATION CATHETERS
First on market country: Türkiye
Authorised representative: -
Last updated: 31.07.2026 01:07

Manufacturer products View details

Spiralleitung 200 cm mit Y-Verbinder

Leitungssysteme für Angiographie, Kardiologie, Radiologie

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: RoweMed AG - Medical 4 Life
Manufacturer SRN: DE-MF-000005350
UDI-DI: 04250347605543
Basic UDI-DI: 42503476LEITUNGSSYSTMEUP
Reference: A-7032/65
EMDN: C01040199
EMDN description: CARDIAC ANGIOGRAPHY DEVICES - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 00:05

Manufacturer products View details

Alvision

Alvision Interventional Cardiology Diagnostic Catheter

Class IIIMDR 2017/745On the marketDirect markingSingle useSterile

Manufacturer: Alvimedica Tibbi Urunler San. ve Dis Tic. A.S.
Manufacturer SRN: TR-MF-000029915
UDI-DI: 08699195507757
Basic UDI-DI: 086991955Alvision5D
Reference: 501110019893
EMDN: C0104010101
EMDN description: CARDIAC ANGIOGRAPHY DIAGNOSTIC CATHETERS
First on market country: Türkiye
Safety summary (SSCP/SSP): SSCP-00001 Alvision_1 · Rev. 1
Authorised representative: -
Last updated: 30.07.2026 20:22

Manufacturer products Open in EUDAMED View details

Invader PTCA

Invader PTCA Balloon Dilatation Catheter

Class IIIMDR 2017/745On the marketDirect markingSingle useSterile

Manufacturer: Alvimedica Tibbi Urunler San. ve Dis Tic. A.S.
Manufacturer SRN: TR-MF-000029915
UDI-DI: 08699195505104
Basic UDI-DI: 086991955InvaderPTCAVA
Reference: 512110021501
EMDN: C010401020101
EMDN description: PTCA BALLOON DILATION CATHETERS
First on market country: Türkiye
Safety summary (SSCP/SSP): SSCP-00002 for Invader PTCA · Rev. 0
Authorised representative: -
Last updated: 30.07.2026 20:22

Manufacturer products Open in EUDAMED View details

Phoenix Atherectomy System

Class IIaMDR 2017/745On the marketActive deviceCMR substanceSingle useSterile

Manufacturer: Philips Image Guided Therapy Corporation
Manufacturer SRN: US-MF-000018632
UDI-DI: 00845225003807
Basic UDI-DI: 08452250BM4066Z
Reference: P15149K
EMDN: C010402020602
EMDN description: PERIPHERAL ATHERECTOMY SYSTEMS, ROTATIONAL
First on market country: Netherlands
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 30.07.2026 20:07

Manufacturer products Authorised representative products Authorised representative actors View details

Phoenix Atherectomy Catheter

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Philips Image Guided Therapy Corporation
Manufacturer SRN: US-MF-000018632
UDI-DI: 00845225003739
Basic UDI-DI: 08452250BM1828Z7
Reference: P15149
EMDN: C010402020602
EMDN description: PERIPHERAL ATHERECTOMY SYSTEMS, ROTATIONAL
First on market country: Netherlands
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 30.07.2026 20:07

Manufacturer products Authorised representative products Authorised representative actors View details

Visions PV .014P RX Digital IVUS Catheter

Visions PV

Class IIaMDR 2017/745On the marketActive deviceSingle useSterile

Manufacturer: Philips Image Guided Therapy Corporation
Manufacturer SRN: US-MF-000018632
UDI-DI: 00845225003227
Basic UDI-DI: 08452250BM37177
Reference: 014R
EMDN: C0104020102
EMDN description: INTRAVASCULAR ULTRASOUND CATHETERS
First on market country: Netherlands
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 30.07.2026 20:07

Manufacturer products Authorised representative products Authorised representative actors View details

Slip-Cath® Beacon® Tip

Slip-Cath® Beacon® Tip Hydrophilic Angiographic Catheter

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Cook Incorporated
Manufacturer SRN: US-MF-000003180
UDI-DI: 00827002598546
Basic UDI-DI: 0827002CINC012-021_B1W3
Reference: SCBR5.0-35-65-P-NS-RBT
EMDN: C0104020101
EMDN description: PANORAMIC AND SELECTIVE PERIPHERAL DIAGNOSTIC ANGIOGRAPHY CATHETERS AND MICROCATHETERS
First on market country: Germany
Authorised representative: COOK MEDICAL EUROPE LIMITED
Last updated: 30.07.2026 20:01

Manufacturer products Authorised representative products Authorised representative actors View details

Torcon

"Diagnostic Visceral Catheters [Beacon® Tip Angiographic Catheter; Torcon Angiographic Catheter] "

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Cook Incorporated
Manufacturer SRN: US-MF-000003180
UDI-DI: 00827002093621
Basic UDI-DI: 0827002CINC012-021_B2W5
Reference: HNB5.0-38-65-P-NS-MPA
EMDN: C0104020101
EMDN description: PANORAMIC AND SELECTIVE PERIPHERAL DIAGNOSTIC ANGIOGRAPHY CATHETERS AND MICROCATHETERS
First on market country: Germany
Authorised representative: COOK MEDICAL EUROPE LIMITED
Last updated: 30.07.2026 20:01

Manufacturer products Authorised representative products Authorised representative actors View details

Dale Transducer Holder

622

Class IMDR 2017/745On the marketSingle use

Manufacturer: Dale Medical Products, Inc.
Manufacturer SRN: US-MF-000019061
UDI-DI: 00817612020957
Basic UDI-DI: 0817612026226M
Reference: 622
EMDN: C010480
EMDN description: ANGIOGRAPHY AND HEMODYNAMICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 30.07.2026 19:59

Manufacturer products Authorised representative products Authorised representative actors View details

Dale Transducer Holder

620

Class IMDR 2017/745On the marketSingle use

Manufacturer: Dale Medical Products, Inc.
Manufacturer SRN: US-MF-000019061
UDI-DI: 00817612020841
Basic UDI-DI: 0817612026206H
Reference: 620
EMDN: C010480
EMDN description: ANGIOGRAPHY AND HEMODYNAMICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 30.07.2026 19:59

Manufacturer products Authorised representative products Authorised representative actors View details