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MV Flow ™ Aspiration Pump

MV Flow™ Aspiration Pump

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Microvention Inc.
Manufacturer SRN: US-MF-000016658
UDI-DI: 00840273213710
Basic UDI-DI: 08402732ASPIRATIONPUMP75
Reference: MVFLOWPMP01-MDR
EMDN: C010402020780
EMDN description: THROMBECTOMY AND PERIPHERAL THROMBOASPIRATION SYSTEMS - ACCESSORIES
First on market country: Netherlands
Authorised representative: MICROVENTION EUROPE
Last updated: 24.09.2026 09:31

Manufacturer products Authorised representative products Authorised representative actors View details

PG Pro™ Peripheral Microcatheter

Class IIaNot specifiedOn the marketSingle useSterile

Manufacturer: Microvention Inc.
Manufacturer SRN: US-MF-000016658
UDI-DI: 00840273210221
Basic UDI-DI: 08402732PGPROHH
Reference: PGP28140STR-01
EMDN: C0104020202
EMDN description: PERIPHERAL EMBOLISATION CATHETERS AND MICROCATHETERS
First on market country: Belgium
Authorised representative: MICROVENTION EUROPE
Last updated: 24.09.2026 09:31

Manufacturer products Authorised representative products Authorised representative actors View details

Mozec™ PTA 0.014" OTW

Class IIaMDR 2017/745On the marketDirect markingSingle useSterile

Manufacturer: Meril Life Sciences Pvt. Ltd.
Manufacturer SRN: IN-MF-000008308
UDI-DI: 18904224916897
Basic UDI-DI: 89042249OPTABDC0147D
Reference: MO14025080B
EMDN: C010402020101
EMDN description: PTA BALLOON DILATATION CATHETERS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 24.09.2026 09:31

Manufacturer products Authorised representative products Authorised representative actors View details

Mozec™ PTA 0.014" OTW

Class IIaMDR 2017/745On the marketDirect markingSingle useSterile

Manufacturer: Meril Life Sciences Pvt. Ltd.
Manufacturer SRN: IN-MF-000008308
UDI-DI: 18904224916880
Basic UDI-DI: 89042249OPTABDC0147D
Reference: MO14025060B
EMDN: C010402020101
EMDN description: PTA BALLOON DILATATION CATHETERS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 24.09.2026 09:30

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Mozec™ PTA 0.014" OTW

Class IIaMDR 2017/745On the marketDirect markingSingle useSterile

Manufacturer: Meril Life Sciences Pvt. Ltd.
Manufacturer SRN: IN-MF-000008308
UDI-DI: 18904224916873
Basic UDI-DI: 89042249OPTABDC0147D
Reference: MO14025050B
EMDN: C010402020101
EMDN description: PTA BALLOON DILATATION CATHETERS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 24.09.2026 09:29

Manufacturer products Authorised representative products Authorised representative actors View details

Mozec™ PTA 0.014" OTW

Class IIaMDR 2017/745On the marketDirect markingSingle useSterile

Manufacturer: Meril Life Sciences Pvt. Ltd.
Manufacturer SRN: IN-MF-000008308
UDI-DI: 18904224916866
Basic UDI-DI: 89042249OPTABDC0147D
Reference: MO14025040B
EMDN: C010402020101
EMDN description: PTA BALLOON DILATATION CATHETERS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 24.09.2026 09:28

Manufacturer products Authorised representative products Authorised representative actors View details

Mozec™ PTA 0.014" OTW

Class IIaMDR 2017/745On the marketDirect markingSingle useSterile

Manufacturer: Meril Life Sciences Pvt. Ltd.
Manufacturer SRN: IN-MF-000008308
UDI-DI: 18904224934341
Basic UDI-DI: 89042249OPTABDC0147D
Reference: MO14040030A
EMDN: C010402020101
EMDN description: PTA BALLOON DILATATION CATHETERS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 24.09.2026 09:20

Manufacturer products Authorised representative products Authorised representative actors View details

swiftPAC Coil, 6 cm

Embolization Coils

Class IIIMDR 2017/745On the marketWell-established tech (possible)CMR substanceImplantableSingle useSterile

Manufacturer: Penumbra, Inc.
Manufacturer SRN: US-MF-000008514
UDI-DI: 00810169721469
Basic UDI-DI: 081454801PCOEU
Reference: 400SWPC06
EMDN: C010402020301
EMDN description: EMBOLISATION COILS
First on market country: Germany
Safety summary (SSCP/SSP): SSCP-21757 · Rev. E
Authorised representative: Penumbra Europe GmbH
Last updated: 24.09.2026 08:52

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

ACCESS25, 150cm, 130° Tip

Vascular Microcatheter

Class IIIMDR 2017/745On the marketSingle useSterile

Manufacturer: Penumbra, Inc.
Manufacturer SRN: US-MF-000008514
UDI-DI: 00815948029781
Basic UDI-DI: 081454801PDMET
Reference: PXAC130
EMDN: C0104020202
EMDN description: PERIPHERAL EMBOLISATION CATHETERS AND MICROCATHETERS
First on market country: Germany
Safety summary (SSCP/SSP): SSCP-23889 · Rev. D
Authorised representative: Penumbra Europe GmbH
Last updated: 24.09.2026 08:44

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swiftPAC Coil, 10 cm

Class IIIMDR 2017/745On the marketWell-established tech (possible)CMR substanceImplantableSingle useSterile

Manufacturer: Penumbra, Inc.
Manufacturer SRN: US-MF-000008514
UDI-DI: 00810169721476
Basic UDI-DI: 081454801PCOEU
Reference: 400SWPC10
EMDN: C010402020301
EMDN description: EMBOLISATION COILS
First on market country: -
Safety summary (SSCP/SSP): SSCP-21757 · Rev. E
Authorised representative: Penumbra Europe GmbH
Last updated: 24.09.2026 08:42

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swiftPAC Coil, 15 cm

Class IIIMDR 2017/745On the marketWell-established tech (possible)CMR substanceImplantableSingle useSterile

Manufacturer: Penumbra, Inc.
Manufacturer SRN: US-MF-000008514
UDI-DI: 00810169721483
Basic UDI-DI: 081454801PCOEU
Reference: 400SWPC15
EMDN: C010402020301
EMDN description: EMBOLISATION COILS
First on market country: -
Safety summary (SSCP/SSP): SSCP-21757 · Rev. E
Authorised representative: Penumbra Europe GmbH
Last updated: 24.09.2026 08:42

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

swiftPAC Coil, 20 cm

Class IIIMDR 2017/745On the marketWell-established tech (possible)CMR substanceImplantableSingle useSterile

Manufacturer: Penumbra, Inc.
Manufacturer SRN: US-MF-000008514
UDI-DI: 00810169721490
Basic UDI-DI: 081454801PCOEU
Reference: 400SWPC20
EMDN: C010402020301
EMDN description: EMBOLISATION COILS
First on market country: -
Safety summary (SSCP/SSP): SSCP-21757 · Rev. E
Authorised representative: Penumbra Europe GmbH
Last updated: 24.09.2026 08:41

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

swiftPAC Coil, 25 cm

Class IIIMDR 2017/745On the marketWell-established tech (possible)CMR substanceImplantableSingle useSterile

Manufacturer: Penumbra, Inc.
Manufacturer SRN: US-MF-000008514
UDI-DI: 00810169721506
Basic UDI-DI: 081454801PCOEU
Reference: 400SWPC25
EMDN: C010402020301
EMDN description: EMBOLISATION COILS
First on market country: -
Safety summary (SSCP/SSP): SSCP-21757 · Rev. E
Authorised representative: Penumbra Europe GmbH
Last updated: 24.09.2026 08:41

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

swiftPAC Coil, 30 cm

Class IIIMDR 2017/745On the marketWell-established tech (possible)CMR substanceImplantableSingle useSterile

Manufacturer: Penumbra, Inc.
Manufacturer SRN: US-MF-000008514
UDI-DI: 00810169721513
Basic UDI-DI: 081454801PCOEU
Reference: 400SWPC30
EMDN: C010402020301
EMDN description: EMBOLISATION COILS
First on market country: -
Safety summary (SSCP/SSP): SSCP-21757 · Rev. E
Authorised representative: Penumbra Europe GmbH
Last updated: 24.09.2026 08:40

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

swiftPAC Coil, 45 cm

Class IIIMDR 2017/745On the marketWell-established tech (possible)CMR substanceImplantableSingle useSterile

Manufacturer: Penumbra, Inc.
Manufacturer SRN: US-MF-000008514
UDI-DI: 00810169721520
Basic UDI-DI: 081454801PCOEU
Reference: 400SWPC45
EMDN: C010402020301
EMDN description: EMBOLISATION COILS
First on market country: -
Safety summary (SSCP/SSP): SSCP-21757 · Rev. E
Authorised representative: Penumbra Europe GmbH
Last updated: 24.09.2026 08:39

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

swiftPAC Coil, 60 cm

Class IIIMDR 2017/745On the marketWell-established tech (possible)CMR substanceImplantableSingle useSterile

Manufacturer: Penumbra, Inc.
Manufacturer SRN: US-MF-000008514
UDI-DI: 00810169721537
Basic UDI-DI: 081454801PCOEU
Reference: 400SWPC60
EMDN: C010402020301
EMDN description: EMBOLISATION COILS
First on market country: -
Safety summary (SSCP/SSP): SSCP-21757 · Rev. E
Authorised representative: Penumbra Europe GmbH
Last updated: 24.09.2026 08:39

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

ACCESS25™, 150cm, Straight Tip

Class IIIMDR 2017/745On the marketSingle useSterile

Manufacturer: Penumbra, Inc.
Manufacturer SRN: US-MF-000008514
UDI-DI: 00815948029798
Basic UDI-DI: 081454801PDMET
Reference: PXACSTR
EMDN: C0104020202
EMDN description: PERIPHERAL EMBOLISATION CATHETERS AND MICROCATHETERS
First on market country: -
Safety summary (SSCP/SSP): SSCP-23889 · Rev. D
Authorised representative: Penumbra Europe GmbH
Last updated: 24.09.2026 08:35

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

Coyote™

Coyote™ Monorail™ and Over-The-Wire PTA Balloon Dilatation Catheters

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729796411
Basic UDI-DI: 01915060000000000000495NR
Reference: H74939186150410
EMDN: C010402020101
EMDN description: PTA BALLOON DILATATION CATHETERS
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 24.09.2026 08:34

Manufacturer products Authorised representative products Authorised representative actors View details

ACCESS25™, 150cm, 45° Tip

Class IIIMDR 2017/745On the marketSingle useSterile

Manufacturer: Penumbra, Inc.
Manufacturer SRN: US-MF-000008514
UDI-DI: 00815948029804
Basic UDI-DI: 081454801PDMET
Reference: PXAC045
EMDN: C0104020202
EMDN description: PERIPHERAL EMBOLISATION CATHETERS AND MICROCATHETERS
First on market country: -
Safety summary (SSCP/SSP): SSCP-23889 · Rev. D
Authorised representative: Penumbra Europe GmbH
Last updated: 24.09.2026 08:33

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

Packing Coil LP 30 cm

Embolization Coils

Class IIIMDR 2017/745On the marketWell-established tech (possible)CMR substanceImplantableSingle useSterile

Manufacturer: Penumbra, Inc.
Manufacturer SRN: US-MF-000008514
UDI-DI: 00810169721247
Basic UDI-DI: 081454801PCOEU
Reference: RBYPCLP30
EMDN: C010402020301
EMDN description: EMBOLISATION COILS
First on market country: Germany
Safety summary (SSCP/SSP): SSCP-21757 · Rev. E
Authorised representative: Penumbra Europe GmbH
Last updated: 24.09.2026 08:32

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