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BioMatrix Alpha Drug Eluting Coronary Stent System

BMX6-2209

Class IIIMDR 2017/745On the marketCMR substanceImplantableMedicinal productSingle useSterile

Manufacturer: Biosensors Europe SA
Manufacturer SRN: CH-MF-000015764
UDI-DI: 08888893018645
Basic UDI-DI: 8888893BMX6HV
Reference: BMX6-2209
EMDN: P070402010301
EMDN description: CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS
First on market country: Netherlands
Safety summary (SSCP/SSP): SSCP-00004 · Rev. 5
Authorised representative: NVT GmbH
Last updated: 01.08.2026 00:12

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

LP0121、LP0124、LP0127、LP0130、LP0133、LP0114Fr

Class IIIMDR 2017/745On the marketImplantableSingle useSterile

Manufacturer: Shanghai Shenqi Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000013667
UDI-DI: 06931473304439
Basic UDI-DI: 69314733LP01QL
Reference: LP0121
EMDN: P07040399
EMDN description: HEART AND CORONARY DEFECT OCCLUDERS - OTHER
First on market country: Italy
Safety summary (SSCP/SSP): CE-LP01-16 · Rev. A/3
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 31.07.2026 18:49

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

Ultimaster Tansei

Ultimaster Tansei Sirolimus eluting coronary stent system

Class IIIMDR 2017/745On the marketCMR substanceImplantableMedicinal productSingle useSterile

Manufacturer: TERUMO EUROPE N.V.
Manufacturer SRN: BE-MF-000001434
UDI-DI: 05413206220977
Basic UDI-DI: 5413206UMTCS
Reference: DE-RQ2515KSM
EMDN: P070402010301
EMDN description: CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS
First on market country: Belgium
Safety summary (SSCP/SSP): PS-10-079en · Rev. 1
Authorised representative: -
Last updated: 31.07.2026 11:00

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Ultimaster Tansei

Ultimaster Tansei Sirolimus eluting coronary stent system

Class IIIMDR 2017/745On the marketCMR substanceImplantableMedicinal productSingle useSterile

Manufacturer: TERUMO EUROPE N.V.
Manufacturer SRN: BE-MF-000001434
UDI-DI: 05413206220953
Basic UDI-DI: 5413206UMTCS
Reference: DE-RQ2512KSM
EMDN: P070402010301
EMDN description: CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS
First on market country: Belgium
Safety summary (SSCP/SSP): PS-10-079en · Rev. 1
Authorised representative: -
Last updated: 31.07.2026 10:52

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Vascular Surgery

VAS 02

Class IIaMDR 2017/745On the marketSterile

Manufacturer: SYNDEO Medical
Manufacturer SRN: BE-PR-000044136
UDI-DI: 05065021834107
Basic UDI-DI: 5065021834SYNPP010Z2
Reference: SYN-VAS02-001
EMDN: P0704020299
EMDN description: PERIPHERAL VASCULAR STENTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 09:17

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Occlutech mVSD Occluder Procedure Pack

Occlutech mVSD Occluder Procedure Pack

Class IIIMDR 2017/745On the market

Manufacturer: Occlutech GmbH
Manufacturer SRN: DE-PR-000049872
UDI-DI: 04260182525395
Basic UDI-DI: 426018252MVSDPPD5
Reference: 71VSD04P
EMDN: P07040301
EMDN description: CARDIAC OCCLUDERS, VENTRICULAR SEPTAL DEFECTS
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 01:41

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Occlutech mVSD Occluder Procedure Pack

Occlutech mVSD Occluder Procedure Pack

Class IIIMDR 2017/745On the market

Manufacturer: Occlutech GmbH
Manufacturer SRN: DE-PR-000049872
UDI-DI: 04260182525371
Basic UDI-DI: 426018252MVSDFLEXII9X
Reference: 71VSD04F
EMDN: P07040301
EMDN description: CARDIAC OCCLUDERS, VENTRICULAR SEPTAL DEFECTS
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 01:41

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Occlutech Paravalvular Leak Device Procedure Pack

Occlutech Paravalvular Leak Device Procedure Pack

Class IIIMDR 2017/745On the market

Manufacturer: Occlutech GmbH
Manufacturer SRN: DE-PR-000049872
UDI-DI: 04260182523063
Basic UDI-DI: 426018252PLDFLEXIRC
Reference: 60PLD05WF
EMDN: P07040399
EMDN description: HEART AND CORONARY DEFECT OCCLUDERS - OTHER
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 01:41

Manufacturer products View details

Occlutech Paravalvular Leak Device Procedure Pack

Occlutech Paravalvular Leak Device Procedure Pack

Class IIIMDR 2017/745On the market

Manufacturer: Occlutech GmbH
Manufacturer SRN: DE-PR-000049872
UDI-DI: 04260182523032
Basic UDI-DI: 426018252PLDPP78
Reference: 60PLD04WP
EMDN: P07040399
EMDN description: HEART AND CORONARY DEFECT OCCLUDERS - OTHER
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 01:40

Manufacturer products View details

Occlutech PDA Occluder Procedure Pack

Occlutech PDA Occluder Procedure Pack

Class IIIMDR 2017/745On the market

Manufacturer: Occlutech GmbH
Manufacturer SRN: DE-PR-000049872
UDI-DI: 04255888902915
Basic UDI-DI: 426018252PDAOOP5U
Reference: 42PDA05O
EMDN: P07040303
EMDN description: CARDIAC OCCLUDERS, FORAMEN OVALE AND BOTALLO DUCT
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 01:37

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Figulla Flex II ASD Occluder Procedure Pack

Figulla Flex II ASD Occluder Procedure Pack

Class IIIMDR 2017/745On the market

Manufacturer: Occlutech GmbH
Manufacturer SRN: DE-PR-000049872
UDI-DI: 04255888901116
Basic UDI-DI: 426018252ASDIIPP9A
Reference: 29ASD04P
EMDN: P07040302
EMDN description: CARDIAC OCCLUDERS, ATRIAL SEPTAL DEFECTS
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 01:37

Manufacturer products View details

Figulla Flex II ASD Occluder Procedure Pack

Figulla Flex II ASD Occluder Procedure Pack

Class IIIMDR 2017/745On the market

Manufacturer: Occlutech GmbH
Manufacturer SRN: DE-PR-000049872
UDI-DI: 04255888901086
Basic UDI-DI: 426018252ASDIIFLEXIIF6
Reference: 29ASD04F
EMDN: P07040302
EMDN description: CARDIAC OCCLUDERS, ATRIAL SEPTAL DEFECTS
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 01:37

Manufacturer products View details

Figulla® Flex II PFO Occluder Procedure Pack

Figulla Flex II PFO Occluder Procedure Pack

Class IIIMDR 2017/745On the market

Manufacturer: Occlutech GmbH
Manufacturer SRN: DE-PR-000049872
UDI-DI: 04255888900331
Basic UDI-DI: 426018252PFOIIIPPTB
Reference: 18PFO25SP
EMDN: P07040303
EMDN description: CARDIAC OCCLUDERS, FORAMEN OVALE AND BOTALLO DUCT
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 01:37

Manufacturer products View details

Figulla Flex II PFO Occluder Procedure Pack

Figulla Flex II PFO Occluder Procedure Pack

Class IIIMDR 2017/745On the market

Manufacturer: Occlutech GmbH
Manufacturer SRN: DE-PR-000049872
UDI-DI: 04255888900317
Basic UDI-DI: 426018252PFOIIIFLEXIIRS
Reference: 18PFO25SF
EMDN: P07040303
EMDN description: CARDIAC OCCLUDERS, FORAMEN OVALE AND BOTALLO DUCT
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 01:37

Manufacturer products View details

Figulla Flex II UNI Occluder Procedure Pack

Figulla Flex II UNI Occluder Procedure Pack

Class IIIMDR 2017/745On the market

Manufacturer: Occlutech GmbH
Manufacturer SRN: DE-PR-000049872
UDI-DI: 04255888900034
Basic UDI-DI: 426018252UNIIIPPKL
Reference: 16UNI17P
EMDN: P07040302
EMDN description: CARDIAC OCCLUDERS, ATRIAL SEPTAL DEFECTS
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 01:37

Manufacturer products View details

Figulla Flex II UNI Occluder Procedure Pack

Figulla Flex II UNI Occluder Procedure Pack

Class IIIMDR 2017/745On the market

Manufacturer: Occlutech GmbH
Manufacturer SRN: DE-PR-000049872
UDI-DI: 04255888900010
Basic UDI-DI: 426018252UNIIIFLEXIIZL
Reference: 16UNI17F
EMDN: P07040302
EMDN description: CARDIAC OCCLUDERS, ATRIAL SEPTAL DEFECTS
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 01:37

Manufacturer products View details

pEGASUS Stent System

Neurovascular Stent

Class IIIMDR 2017/745On the marketImplantableSingle useSterile

Manufacturer: phenox GmbH
Manufacturer SRN: DE-MF-000006524
UDI-DI: 04260123784645
Basic UDI-DI: 426012378NeuroStentTE
Reference: PEGASUS-350-15
EMDN: P070402020102
EMDN description: NON-STAINLESS STEEL PERIPHERAL VASCULAR BARE METAL STENTS
First on market country: Germany
Safety summary (SSCP/SSP): 67.30.001_SSCP-0005 · Rev. A
Authorised representative: -
Last updated: 31.07.2026 01:31

Manufacturer products Open in EUDAMED View details

pCONUS2 Bifurcation Aneurysm Implant

Bifurcation Aneurysm Implant

Class IIIMDR 2017/745On the marketCMR substanceImplantableSingle useSterile

Manufacturer: phenox GmbH
Manufacturer SRN: DE-MF-000006524
UDI-DI: 04260123784225
Basic UDI-DI: 426012378BifurImplantGK
Reference: PCON2-4-15-5
EMDN: P070402020102
EMDN description: NON-STAINLESS STEEL PERIPHERAL VASCULAR BARE METAL STENTS
First on market country: Germany
Safety summary (SSCP/SSP): 67.30.001 · Rev. A
Authorised representative: -
Last updated: 31.07.2026 01:31

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p64 Flow Modulation Device

Neurovascular Flow Diverter

Class IIIMDR 2017/745On the marketImplantableSingle useSterile

Manufacturer: phenox GmbH
Manufacturer SRN: DE-MF-000006524
UDI-DI: 04260123783198
Basic UDI-DI: 426012378FlowDiverterSV
Reference: p64-250-9
EMDN: P070402020102
EMDN description: NON-STAINLESS STEEL PERIPHERAL VASCULAR BARE METAL STENTS
First on market country: Germany
Safety summary (SSCP/SSP): 67.30.001_SSCP-FLOW DIVERTER · Rev. B
Authorised representative: -
Last updated: 31.07.2026 01:31

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DynamX Sirolimus Eluting Coronary Bioadaptor System

VIR2014

Class IIIMDR 2017/745On the marketCMR substanceImplantableMedicinal productSingle useSterile

Manufacturer: Elixir Medical Corporation
Manufacturer SRN: US-MF-000013041
UDI-DI: 00817508012790
Basic UDI-DI: 081750801DynamXVIR4F
Reference: VIR2214
EMDN: P07040199
EMDN description: VASCULAR ENDOPROSTHESES - OTHER
First on market country: Sweden
Safety summary (SSCP/SSP): LBL00369 · 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