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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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Allurion Gastric Balloon System

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Class IIbNot specifiedOn the marketSingle use

Manufacturer: Allurion Technologies Inc.
Manufacturer SRN: US-MF-000001377
UDI-DI: D-10B7B
Basic UDI-DI: B-10B7B
Reference: 10B
EMDN: G030601
EMDN description: INTRAGASTRIC BALLOON SYSTEMS
First on market country: France
Authorised representative: ICON (LR) Limited
Last updated: 11.07.2026 05:46

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20-00189

Class IIbMDDNo longer on the marketActive deviceSingle useSterile

Manufacturer: CSA Medical
Manufacturer SRN: US-MF-000026367
UDI-DI: 10857068006126
Basic UDI-DI: B-10857068006126
Reference: 20-00189
EMDN: R0799
EMDN description: BRONCOPULMONARY ENDOSCOPY DEVICES, SINGLE-USE - OTHER
First on market country: -
Authorised representative: ICON (LR) Limited
Last updated: 11.07.2026 04:42

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Class IIIMDR 2017/745On the marketImplantableSingle useSterile

Manufacturer: SI-BONE, Inc.
Manufacturer SRN: US-MF-000028624
UDI-DI: 00851085007343
Basic UDI-DI: 081005552ifuse3DimplantSG
Reference: 7040M-90
EMDN: P09070199
EMDN description: SPINAL FUSION SYSTEMS - OTHER
First on market country: -
Safety summary (SSCP/SSP): 301000 · Rev. F
Authorised representative: ICON (LR) Limited
Last updated: 09.07.2026 00:37

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Class IIIMDR 2017/745On the marketImplantableSingle useSterile

Manufacturer: SI-BONE, Inc.
Manufacturer SRN: US-MF-000028624
UDI-DI: 00851085007350
Basic UDI-DI: 081005552ifuse3DimplantSG
Reference: 7045M-90
EMDN: P09070199
EMDN description: SPINAL FUSION SYSTEMS - OTHER
First on market country: -
Safety summary (SSCP/SSP): 301000 · Rev. F
Authorised representative: ICON (LR) Limited
Last updated: 09.07.2026 00:37

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: SI-BONE, Inc.
Manufacturer SRN: US-MF-000028624
UDI-DI: 00851085007367
Basic UDI-DI: 081005552ifuse3DimplantSG
Reference: 7050M-90
EMDN: P09070199
EMDN description: SPINAL FUSION SYSTEMS - OTHER
First on market country: -
Safety summary (SSCP/SSP): 301000 · Rev. F
Authorised representative: ICON (LR) Limited
Last updated: 09.07.2026 00:37

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: SI-BONE, Inc.
Manufacturer SRN: US-MF-000028624
UDI-DI: 00851085007374
Basic UDI-DI: 081005552ifuse3DimplantSG
Reference: 7055M-90
EMDN: P09070199
EMDN description: SPINAL FUSION SYSTEMS - OTHER
First on market country: -
Safety summary (SSCP/SSP): 301000 · Rev. F
Authorised representative: ICON (LR) Limited
Last updated: 09.07.2026 00:37

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: SI-BONE, Inc.
Manufacturer SRN: US-MF-000028624
UDI-DI: 00851085007381
Basic UDI-DI: 081005552ifuse3DimplantSG
Reference: 7060M-90
EMDN: P09070199
EMDN description: SPINAL FUSION SYSTEMS - OTHER
First on market country: -
Safety summary (SSCP/SSP): 301000 · Rev. F
Authorised representative: ICON (LR) Limited
Last updated: 09.07.2026 00:37

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: SI-BONE, Inc.
Manufacturer SRN: US-MF-000028624
UDI-DI: 00851085007442
Basic UDI-DI: 081005552ifuse3DimplantSG
Reference: 7065M-90
EMDN: P09070199
EMDN description: SPINAL FUSION SYSTEMS - OTHER
First on market country: -
Safety summary (SSCP/SSP): 301000 · Rev. F
Authorised representative: ICON (LR) Limited
Last updated: 09.07.2026 00:37

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: SI-BONE, Inc.
Manufacturer SRN: US-MF-000028624
UDI-DI: 00851085007527
Basic UDI-DI: 081005552ifuse3DimplantSG
Reference: 7075M-90
EMDN: P09070199
EMDN description: SPINAL FUSION SYSTEMS - OTHER
First on market country: -
Safety summary (SSCP/SSP): 301000 · Rev. F
Authorised representative: ICON (LR) Limited
Last updated: 09.07.2026 00:37

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: SI-BONE, Inc.
Manufacturer SRN: US-MF-000028624
UDI-DI: 00851085007541
Basic UDI-DI: 081005552ifuse3DimplantSG
Reference: 7070M-90
EMDN: P09070199
EMDN description: SPINAL FUSION SYSTEMS - OTHER
First on market country: -
Safety summary (SSCP/SSP): 301000 · Rev. F
Authorised representative: ICON (LR) Limited
Last updated: 09.07.2026 00:37

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: SI-BONE, Inc.
Manufacturer SRN: US-MF-000028624
UDI-DI: 00851085007558
Basic UDI-DI: 081005552ifuse3DimplantSG
Reference: 7080M-90
EMDN: P09070199
EMDN description: SPINAL FUSION SYSTEMS - OTHER
First on market country: -
Safety summary (SSCP/SSP): 301000 · Rev. F
Authorised representative: ICON (LR) Limited
Last updated: 09.07.2026 00:37

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: SI-BONE, Inc.
Manufacturer SRN: US-MF-000028624
UDI-DI: 00851085007565
Basic UDI-DI: 081005552ifuse3DimplantSG
Reference: 7085M-90
EMDN: P09070199
EMDN description: SPINAL FUSION SYSTEMS - OTHER
First on market country: -
Safety summary (SSCP/SSP): 301000 · Rev. F
Authorised representative: ICON (LR) Limited
Last updated: 09.07.2026 00:37

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: SI-BONE, Inc.
Manufacturer SRN: US-MF-000028624
UDI-DI: 00851085007572
Basic UDI-DI: 081005552ifuse3DimplantSG
Reference: 7090M-90
EMDN: P09070199
EMDN description: SPINAL FUSION SYSTEMS - OTHER
First on market country: -
Safety summary (SSCP/SSP): 301000 · Rev. F
Authorised representative: ICON (LR) Limited
Last updated: 09.07.2026 00:37

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

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Class IIbMDR 2017/745On the marketImplantableSingle useSterileSutures

Manufacturer: SI-BONE, Inc.
Manufacturer SRN: US-MF-000028624
UDI-DI: 00810055524228
Basic UDI-DI: 081005552tntimplantNE
Reference: 870070
EMDN: P09120603
EMDN description: CANNULATED SCREWS
First on market country: -
Authorised representative: ICON (LR) Limited
Last updated: 08.07.2026 22:46

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Liberty Thumb Spica Right Sm/Med

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Class IMDR 2017/745On the marketDirect marking

Manufacturer: North Coast Medical Inc.
Manufacturer SRN: US-MF-000009087
UDI-DI: 00768627146418
Basic UDI-DI: 0768627ORTHO-1254-N6
Reference: NC14641
EMDN: Y060613
EMDN description: WRIST-HAND-FINGERS ORTHOSES
First on market country: -
Authorised representative: ICON (LR) Limited
Last updated: 08.07.2026 10:08

Manufacturer products Authorised representative products Authorised representative actors View details

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Class IIINot specifiedOn the marketAnimal tissuesSingle useSterile

Manufacturer: Farapulse Inc
Manufacturer SRN: US-MF-000017969
UDI-DI: 00810087180072
Basic UDI-DI: B-00810087180072
Reference: 21M402
EMDN: -
EMDN description: CARDIOVASCULAR INTRODUCER SHEATHS, VALVED
First on market country: Netherlands
Authorised representative: ICON (LR) Limited
Last updated: 08.07.2026 09:59

Manufacturer products Authorised representative products Authorised representative actors View details

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Class IIINot specifiedOn the marketActive deviceAnimal tissuesSingle useSterile

Manufacturer: Farapulse Inc
Manufacturer SRN: US-MF-000017969
UDI-DI: 00810087180096
Basic UDI-DI: B-00810087180096
Reference: 41M401
EMDN: -
EMDN description: ARRHYTHMOGENIC FOCI PULSED FIELD ABLATION CATHETERS
First on market country: Netherlands
Authorised representative: ICON (LR) Limited
Last updated: 08.07.2026 09:58

Manufacturer products Authorised representative products Authorised representative actors View details

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Class IIINot specifiedOn the marketActive deviceAnimal tissuesSingle useSterile

Manufacturer: Farapulse Inc
Manufacturer SRN: US-MF-000017969
UDI-DI: 00810087180102
Basic UDI-DI: B-00810087180102
Reference: 41M402
EMDN: -
EMDN description: ARRHYTHMOGENIC FOCI PULSED FIELD ABLATION CATHETERS
First on market country: Netherlands
Authorised representative: ICON (LR) Limited
Last updated: 08.07.2026 09:58

Manufacturer products Authorised representative products Authorised representative actors View details

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Class IIINot specifiedOn the marketSingle useSterile

Manufacturer: Farapulse Inc
Manufacturer SRN: US-MF-000017969
UDI-DI: 00810087180119
Basic UDI-DI: B-00810087180119
Reference: 41M404
EMDN: -
EMDN description: ARRHYTHMOGENIC FOCI PULSED FIELD ABLATION CATHETERS
First on market country: Netherlands
Authorised representative: ICON (LR) Limited
Last updated: 08.07.2026 09:58

Manufacturer products Authorised representative products Authorised representative actors View details

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Class IIbMDR 2017/745On the marketActive device

Manufacturer: Farapulse Inc
Manufacturer SRN: US-MF-000017969
UDI-DI: 00810087181314
Basic UDI-DI: 081008718FARAGYE
Reference: M004PFCE61M400
EMDN: C020399
EMDN description: CARDIAC TISSUE ABLATION DEVICES - OTHER
First on market country: -
Authorised representative: ICON (LR) Limited
Last updated: 08.07.2026 09:58

Manufacturer products Authorised representative products Authorised representative actors View details