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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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21.09.2026 20:48

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604 device results listed.

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SEAL™ Embolization System

Class IIIMDR 2017/745On the marketImplantableSingle useSterile

Manufacturer: Galaxy Therapeutics, Inc.
Manufacturer SRN: US-MF-000035675
UDI-DI: 00850052512163
Basic UDI-DI: 0850052512SEALSV
Reference: FG0006-01E
EMDN: C01050299
EMDN description: INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER
First on market country: Spain
Safety summary (SSCP/SSP): TD01-SSCP · Rev. 02
Authorised representative: Specculo Limited
Last updated: 06.08.2026 16:23

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

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Class IIIMDR 2017/745On the marketImplantableSingle useSterile

Manufacturer: Galaxy Therapeutics, Inc.
Manufacturer SRN: US-MF-000035675
UDI-DI: 00850052512170
Basic UDI-DI: 0850052512SEALSV
Reference: FG0006-02E
EMDN: C01050299
EMDN description: INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER
First on market country: -
Safety summary (SSCP/SSP): TD01-SSCP · Rev. 02
Authorised representative: Specculo Limited
Last updated: 06.08.2026 16:19

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

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Class IIIMDR 2017/745On the marketImplantableSingle useSterile

Manufacturer: Galaxy Therapeutics, Inc.
Manufacturer SRN: US-MF-000035675
UDI-DI: 00850052512187
Basic UDI-DI: 0850052512SEALSV
Reference: FG0006-03E
EMDN: C01050299
EMDN description: INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER
First on market country: -
Safety summary (SSCP/SSP): TD01-SSCP · Rev. 02
Authorised representative: Specculo Limited
Last updated: 06.08.2026 16:19

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

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Class IIIMDR 2017/745On the marketImplantableSingle useSterile

Manufacturer: Galaxy Therapeutics, Inc.
Manufacturer SRN: US-MF-000035675
UDI-DI: 00850052512194
Basic UDI-DI: 0850052512SEALSV
Reference: FG0006-04E
EMDN: C01050299
EMDN description: INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER
First on market country: -
Safety summary (SSCP/SSP): TD01-SSCP · Rev. 02
Authorised representative: Specculo Limited
Last updated: 06.08.2026 16:19

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

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Class IIIMDR 2017/745On the marketImplantableSingle useSterile

Manufacturer: Galaxy Therapeutics, Inc.
Manufacturer SRN: US-MF-000035675
UDI-DI: 00850052512200
Basic UDI-DI: 0850052512SEALSV
Reference: FG0006-05E
EMDN: C01050299
EMDN description: INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER
First on market country: -
Safety summary (SSCP/SSP): TD01-SSCP · Rev. 02
Authorised representative: Specculo Limited
Last updated: 06.08.2026 16:19

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

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Class IIIMDR 2017/745On the marketImplantableSingle useSterile

Manufacturer: Galaxy Therapeutics, Inc.
Manufacturer SRN: US-MF-000035675
UDI-DI: 00850052512217
Basic UDI-DI: 0850052512SEALSV
Reference: FG0006-06E
EMDN: C01050299
EMDN description: INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER
First on market country: -
Safety summary (SSCP/SSP): TD01-SSCP · Rev. 02
Authorised representative: Specculo Limited
Last updated: 06.08.2026 16:19

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

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Class IIIMDR 2017/745On the marketImplantableSingle useSterile

Manufacturer: Galaxy Therapeutics, Inc.
Manufacturer SRN: US-MF-000035675
UDI-DI: 00850052512224
Basic UDI-DI: 0850052512SEALSV
Reference: FG0006-07E
EMDN: C01050299
EMDN description: INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER
First on market country: -
Safety summary (SSCP/SSP): TD01-SSCP · Rev. 02
Authorised representative: Specculo Limited
Last updated: 06.08.2026 16:19

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

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Class IIIMDR 2017/745On the marketImplantableSingle useSterile

Manufacturer: Galaxy Therapeutics, Inc.
Manufacturer SRN: US-MF-000035675
UDI-DI: 00850052512231
Basic UDI-DI: 0850052512SEALSV
Reference: FG0007-01E
EMDN: C01050299
EMDN description: INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER
First on market country: -
Safety summary (SSCP/SSP): TD01-SSCP · Rev. 02
Authorised representative: Specculo Limited
Last updated: 06.08.2026 16:19

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

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Class IIIMDR 2017/745On the marketImplantableSingle useSterile

Manufacturer: Galaxy Therapeutics, Inc.
Manufacturer SRN: US-MF-000035675
UDI-DI: 00850052512248
Basic UDI-DI: 0850052512SEALSV
Reference: FG0007-02E
EMDN: C01050299
EMDN description: INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER
First on market country: -
Safety summary (SSCP/SSP): TD01-SSCP · Rev. 02
Authorised representative: Specculo Limited
Last updated: 06.08.2026 16:19

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

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Class IIIMDR 2017/745On the marketImplantableSingle useSterile

Manufacturer: Galaxy Therapeutics, Inc.
Manufacturer SRN: US-MF-000035675
UDI-DI: 00850052512255
Basic UDI-DI: 0850052512SEALSV
Reference: FG0007-03E
EMDN: C01050299
EMDN description: INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER
First on market country: -
Safety summary (SSCP/SSP): TD01-SSCP · Rev. 02
Authorised representative: Specculo Limited
Last updated: 06.08.2026 16:19

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

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Class IIIMDR 2017/745On the marketImplantableSingle useSterile

Manufacturer: Galaxy Therapeutics, Inc.
Manufacturer SRN: US-MF-000035675
UDI-DI: 00850052512262
Basic UDI-DI: 0850052512SEALSV
Reference: FG0007-04E
EMDN: C01050299
EMDN description: INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER
First on market country: -
Safety summary (SSCP/SSP): TD01-SSCP · Rev. 02
Authorised representative: Specculo Limited
Last updated: 06.08.2026 16:19

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

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Class IIIMDR 2017/745On the marketImplantableSingle useSterile

Manufacturer: Galaxy Therapeutics, Inc.
Manufacturer SRN: US-MF-000035675
UDI-DI: 00850052512279
Basic UDI-DI: 0850052512SEALSV
Reference: FG0007-05E
EMDN: C01050299
EMDN description: INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER
First on market country: -
Safety summary (SSCP/SSP): TD01-SSCP · Rev. 02
Authorised representative: Specculo Limited
Last updated: 06.08.2026 16:19

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

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Class IIIMDR 2017/745On the marketImplantableSingle useSterile

Manufacturer: Galaxy Therapeutics, Inc.
Manufacturer SRN: US-MF-000035675
UDI-DI: 00850052512286
Basic UDI-DI: 0850052512SEALSV
Reference: FG0007-06E
EMDN: C01050299
EMDN description: INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER
First on market country: -
Safety summary (SSCP/SSP): TD01-SSCP · Rev. 02
Authorised representative: Specculo Limited
Last updated: 06.08.2026 16:19

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

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Class IIIMDR 2017/745On the marketImplantableSingle useSterile

Manufacturer: Galaxy Therapeutics, Inc.
Manufacturer SRN: US-MF-000035675
UDI-DI: 00850052512293
Basic UDI-DI: 0850052512SEALSV
Reference: FG0007-07E
EMDN: C01050299
EMDN description: INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER
First on market country: -
Safety summary (SSCP/SSP): TD01-SSCP · Rev. 02
Authorised representative: Specculo Limited
Last updated: 06.08.2026 16:19

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

TJEP08-320

Class IIIMDDOn the marketSingle useSterile

Manufacturer: Beijing Taijieweiye Technology Co., Ltd.
Manufacturer SRN: CN-MF-000004540
UDI-DI: 06926724000949
Basic UDI-DI: B-06926724000949
Reference: TJEP08-320
EMDN: C01050202
EMDN description: PTA EMBOLIC PROTECTION CATHETERS AND SYSTEMS
First on market country: Poland
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 03.08.2026 11:06

Manufacturer products Authorised representative products Authorised representative actors View details

TJEP07-320

Class IIIMDDOn the marketSingle useSterile

Manufacturer: Beijing Taijieweiye Technology Co., Ltd.
Manufacturer SRN: CN-MF-000004540
UDI-DI: 06926724000932
Basic UDI-DI: B-06926724000932
Reference: TJEP07-320
EMDN: C01050202
EMDN description: PTA EMBOLIC PROTECTION CATHETERS AND SYSTEMS
First on market country: Poland
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 03.08.2026 11:06

Manufacturer products Authorised representative products Authorised representative actors View details

TJEP06-320

Class IIIMDDOn the marketSingle useSterile

Manufacturer: Beijing Taijieweiye Technology Co., Ltd.
Manufacturer SRN: CN-MF-000004540
UDI-DI: 06926724000925
Basic UDI-DI: B-06926724000925
Reference: TJEP06-320
EMDN: C01050202
EMDN description: PTA EMBOLIC PROTECTION CATHETERS AND SYSTEMS
First on market country: Poland
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 03.08.2026 11:06

Manufacturer products Authorised representative products Authorised representative actors View details

TJEP05-320

Class IIIMDDOn the marketSingle useSterile

Manufacturer: Beijing Taijieweiye Technology Co., Ltd.
Manufacturer SRN: CN-MF-000004540
UDI-DI: 06926724000918
Basic UDI-DI: B-06926724000918
Reference: TJEP05-320
EMDN: C01050202
EMDN description: PTA EMBOLIC PROTECTION CATHETERS AND SYSTEMS
First on market country: Poland
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 03.08.2026 11:06

Manufacturer products Authorised representative products Authorised representative actors View details

TJEP04-320

Class IIIMDDOn the marketSingle useSterile

Manufacturer: Beijing Taijieweiye Technology Co., Ltd.
Manufacturer SRN: CN-MF-000004540
UDI-DI: 06926724000901
Basic UDI-DI: B-06926724000901
Reference: TJEP04-320
EMDN: C01050202
EMDN description: PTA EMBOLIC PROTECTION CATHETERS AND SYSTEMS
First on market country: Poland
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 03.08.2026 11:06

Manufacturer products Authorised representative products Authorised representative actors View details

TJEP03-320

Class IIIMDDOn the marketSingle useSterile

Manufacturer: Beijing Taijieweiye Technology Co., Ltd.
Manufacturer SRN: CN-MF-000004540
UDI-DI: 06926724000895
Basic UDI-DI: B-06926724000895
Reference: TJEP03-320
EMDN: C01050202
EMDN description: PTA EMBOLIC PROTECTION CATHETERS AND SYSTEMS
First on market country: Poland
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 03.08.2026 11:06

Manufacturer products Authorised representative products Authorised representative actors View details