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EUDAMED Device Search

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

Last updated

21.09.2026 21:15

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Active filter:Authorised representative SRN:MT-AR-000034988

175 device results listed.

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Class IMDR 2017/745Not intended for EU marketSingle use

Manufacturer: SS Global
Manufacturer SRN: KR-MF-000026348
UDI-DI: 08800144600256
Basic UDI-DI: 88001446CYCLEANCORDNJY
Reference: 1
EMDN: Q010204
EMDN description: RETRACTION WIRES AND GINGIVAL RETRACTORS
First on market country: -
Authorised representative: Specculo Limited
Last updated: 11.08.2026 23:01

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Class IMDR 2017/745Not intended for EU marketSingle use

Manufacturer: SS Global
Manufacturer SRN: KR-MF-000026348
UDI-DI: 08800144600201
Basic UDI-DI: 88001446CYCLEANCORDPG
Reference: 2
EMDN: Q010204
EMDN description: RETRACTION WIRES AND GINGIVAL RETRACTORS
First on market country: -
Authorised representative: Specculo Limited
Last updated: 10.08.2026 22:52

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Class IMDR 2017/745Not intended for EU marketSingle use

Manufacturer: SS Global
Manufacturer SRN: KR-MF-000026348
UDI-DI: 08800144600171
Basic UDI-DI: 88001446CYCLEANCORDPG
Reference: 00
EMDN: Q010204
EMDN description: RETRACTION WIRES AND GINGIVAL RETRACTORS
First on market country: -
Authorised representative: Specculo Limited
Last updated: 10.08.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

CyClean Cord

Class IMDR 2017/745Not intended for EU marketSingle use

Manufacturer: SS Global
Manufacturer SRN: KR-MF-000026348
UDI-DI: 08800144600157
Basic UDI-DI: 88001446CYCLEANCORDPG
Reference: 000.0
EMDN: Q010204
EMDN description: RETRACTION WIRES AND GINGIVAL RETRACTORS
First on market country: -
Authorised representative: Specculo Limited
Last updated: 10.08.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

Manta Automated Sample Prep Robot

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: CAMBRIAN BIOTECH PRIVATE LIMITED
Manufacturer SRN: IN-MF-000046319
UDI-DI: 08906193750000
Basic UDI-DI: 890619375CBWM100-CAL
Reference: CBWM100-C
EMDN: W02060199
EMDN description: ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER
First on market country: Spain
Authorised representative: Specculo Limited
Last updated: 07.08.2026 20:57

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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

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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

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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

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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

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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

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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

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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

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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

EarGym

Class IMDR 2017/745No longer on the marketActive device

Manufacturer: Eargym Ltd
Manufacturer SRN: UK-MF-000044936
UDI-DI: 15070003410405
Basic UDI-DI: 50700034104eargymJS
Reference: EarGym
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Malta
Authorised representative: Specculo Limited
Last updated: 05.08.2026 16:14

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