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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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00869826000300

Sleeve

Class IMDR 2017/745On the marketDirect markingReusable

Manufacturer: SI-BONE, Inc.
Manufacturer SRN: US-MF-000028624
UDI-DI: 00869826000300
Basic UDI-DI: 081005552SleeveSY
Reference: 500241
EMDN: L0922
EMDN description: ORTHOPAEDIC SURGERY GUIDES, REUSABLE
First on market country: Germany
Authorised representative: ICON (LR) Limited
Last updated: 30.07.2026 19:51

Manufacturer products Authorised representative products Authorised representative actors View details

Paradise™

PRDS-RM

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: ReCor Medical, Inc.
Manufacturer SRN: US-MF-000027816
UDI-DI: 00810008950098
Basic UDI-DI: 081000895ParadiseRemoteR2
Reference: PRDS-RM
EMDN: Z129080
EMDN description: VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: ICON (LR) Limited
Last updated: 30.07.2026 19:48

Manufacturer products Authorised representative products Authorised representative actors View details

Preferred

Class INot specifiedOn the marketDirect marking

Manufacturer: North Coast Medical Inc.
Manufacturer SRN: US-MF-000009087
UDI-DI: 10768627002131
Basic UDI-DI: 0768627CSTACC-1002-QD
Reference: NC12793-1
EMDN: M030504
EMDN description: IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES
First on market country: -
Authorised representative: ICON (LR) Limited
Last updated: 23.07.2026 11:47

Manufacturer products Authorised representative products Authorised representative actors View details

Omega Max

Class INot specifiedOn the marketDirect marking

Manufacturer: North Coast Medical Inc.
Manufacturer SRN: US-MF-000009087
UDI-DI: 10768627002179
Basic UDI-DI: 0768627CSTACC-1027-R6
Reference: NC12798-1
EMDN: M030504
EMDN description: IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES
First on market country: -
Authorised representative: ICON (LR) Limited
Last updated: 23.07.2026 11:47

Manufacturer products Authorised representative products Authorised representative actors View details

Prism

Class INot specifiedOn the marketDirect marking

Manufacturer: North Coast Medical Inc.
Manufacturer SRN: US-MF-000009087
UDI-DI: 10768627002438
Basic UDI-DI: 0768627CSTACC-2386-SZ
Reference: NC12956-1
EMDN: M030504
EMDN description: IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES
First on market country: -
Authorised representative: ICON (LR) Limited
Last updated: 23.07.2026 11:47

Manufacturer products Authorised representative products Authorised representative actors View details

Prism

Class INot specifiedOn the marketDirect marking

Manufacturer: North Coast Medical Inc.
Manufacturer SRN: US-MF-000009087
UDI-DI: 10768627002452
Basic UDI-DI: 0768627CSTACC-2386-SZ
Reference: NC12957-1
EMDN: M030504
EMDN description: IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES
First on market country: -
Authorised representative: ICON (LR) Limited
Last updated: 23.07.2026 11:47

Manufacturer products Authorised representative products Authorised representative actors View details

Prism

Class INot specifiedOn the marketDirect marking

Manufacturer: North Coast Medical Inc.
Manufacturer SRN: US-MF-000009087
UDI-DI: 10768627002469
Basic UDI-DI: 0768627CSTACC-2386-SZ
Reference: NC12958-1
EMDN: M030504
EMDN description: IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES
First on market country: -
Authorised representative: ICON (LR) Limited
Last updated: 23.07.2026 11:47

Manufacturer products Authorised representative products Authorised representative actors View details

Prism

Class INot specifiedOn the marketDirect marking

Manufacturer: North Coast Medical Inc.
Manufacturer SRN: US-MF-000009087
UDI-DI: 10768627002483
Basic UDI-DI: 0768627CSTACC-2386-SZ
Reference: NC12964-1
EMDN: M030504
EMDN description: IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES
First on market country: -
Authorised representative: ICON (LR) Limited
Last updated: 23.07.2026 11:47

Manufacturer products Authorised representative products Authorised representative actors View details

00810055520022

iFuse TORQ implant

Class IIbMDR 2017/745On the marketImplantableSingle useSterileSutures

Manufacturer: SI-BONE, Inc.
Manufacturer SRN: US-MF-000028624
UDI-DI: 00810055520022
Basic UDI-DI: 081005552torqimplantFN
Reference: 10030T
EMDN: P09120603
EMDN description: CANNULATED SCREWS
First on market country: Germany
Authorised representative: ICON (LR) Limited
Last updated: 17.07.2026 05:15

Manufacturer products Authorised representative products Authorised representative actors View details

10865707000435

EDG Ortho 65mm (pack of 10)

Class IIaMDDOn the marketActive deviceContains latexMeasuring functionSingle useSterile

Manufacturer: EDGe Surgical, Inc
Manufacturer SRN: US-MF-000052496
UDI-DI: 10865707000435
Basic UDI-DI: B-10865707000435
Reference: 21342-65-10-10-LN
EMDN: Z12139085
EMDN description: VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - CONSUMABLES
First on market country: Greece
Authorised representative: ICON (LR) Limited
Last updated: 17.07.2026 01:39

Manufacturer products Authorised representative products Authorised representative actors View details

Heart Hugger

Heart Hugger Sternum Support Harness

Class IMDR 2017/745On the marketActive deviceSingle use

Manufacturer: General Cardiac Technology, Inc.
Manufacturer SRN: US-MF-000033435
UDI-DI: 00867839000409
Basic UDI-DI: 08678390004HH001V4
Reference: GT500-Small
EMDN: Y0699
EMDN description: EXTERNAL PROSTHESES AND ORTHOSES - OTHER
First on market country: Ireland
Authorised representative: ICON (LR) Limited
Last updated: 16.07.2026 07:00

Manufacturer products Authorised representative products Authorised representative actors View details

SONAS

100172

Class IMDR 2017/745On the marketDirect markingSingle use

Manufacturer: Burl Concepts, Inc.
Manufacturer SRN: US-MF-000029626
UDI-DI: 00860008615848
Basic UDI-DI: 08600086158GPKRJ
Reference: 100172
EMDN: Z12109006
EMDN description: BRAIN TISSUE MONITORING SYSTEMS
First on market country: Germany
Authorised representative: ICON (LR) Limited
Last updated: 16.07.2026 06:52

Manufacturer products Authorised representative products Authorised representative actors View details

SONAS

100052

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Burl Concepts, Inc.
Manufacturer SRN: US-MF-000029626
UDI-DI: 00860008615824
Basic UDI-DI: 08600086158SONASVN
Reference: 100052
EMDN: Z12109006
EMDN description: BRAIN TISSUE MONITORING SYSTEMS
First on market country: Germany
Authorised representative: ICON (LR) Limited
Last updated: 16.07.2026 06:52

Manufacturer products Authorised representative products Authorised representative actors View details

00810055520039

Class IIbMDR 2017/745On the marketImplantableSingle useSterileSutures

Manufacturer: SI-BONE, Inc.
Manufacturer SRN: US-MF-000028624
UDI-DI: 00810055520039
Basic UDI-DI: 081005552torqimplantFN
Reference: 10035T
EMDN: P09120603
EMDN description: CANNULATED SCREWS
First on market country: -
Authorised representative: ICON (LR) Limited
Last updated: 16.07.2026 06:47

Manufacturer products Authorised representative products Authorised representative actors View details

00810055520046

Class IIbMDR 2017/745On the marketImplantableSingle useSterileSutures

Manufacturer: SI-BONE, Inc.
Manufacturer SRN: US-MF-000028624
UDI-DI: 00810055520046
Basic UDI-DI: 081005552torqimplantFN
Reference: 10040T
EMDN: P09120603
EMDN description: CANNULATED SCREWS
First on market country: -
Authorised representative: ICON (LR) Limited
Last updated: 16.07.2026 06:47

Manufacturer products Authorised representative products Authorised representative actors View details

00810055520053

Class IIbMDR 2017/745On the marketImplantableSingle useSterileSutures

Manufacturer: SI-BONE, Inc.
Manufacturer SRN: US-MF-000028624
UDI-DI: 00810055520053
Basic UDI-DI: 081005552torqimplantFN
Reference: 10045T
EMDN: P09120603
EMDN description: CANNULATED SCREWS
First on market country: -
Authorised representative: ICON (LR) Limited
Last updated: 16.07.2026 06:47

Manufacturer products Authorised representative products Authorised representative actors View details

00810055520060

Class IIbMDR 2017/745On the marketImplantableSingle useSterileSutures

Manufacturer: SI-BONE, Inc.
Manufacturer SRN: US-MF-000028624
UDI-DI: 00810055520060
Basic UDI-DI: 081005552torqimplantFN
Reference: 10050T
EMDN: P09120603
EMDN description: CANNULATED SCREWS
First on market country: -
Authorised representative: ICON (LR) Limited
Last updated: 16.07.2026 06:47

Manufacturer products Authorised representative products Authorised representative actors View details

00810055520077

Class IIbMDR 2017/745On the marketImplantableSingle useSterileSutures

Manufacturer: SI-BONE, Inc.
Manufacturer SRN: US-MF-000028624
UDI-DI: 00810055520077
Basic UDI-DI: 081005552torqimplantFN
Reference: 10055T
EMDN: P09120603
EMDN description: CANNULATED SCREWS
First on market country: -
Authorised representative: ICON (LR) Limited
Last updated: 16.07.2026 06:47

Manufacturer products Authorised representative products Authorised representative actors View details

00810055520084

Class IIbMDR 2017/745On the marketImplantableSingle useSterileSutures

Manufacturer: SI-BONE, Inc.
Manufacturer SRN: US-MF-000028624
UDI-DI: 00810055520084
Basic UDI-DI: 081005552torqimplantFN
Reference: 10060T
EMDN: P09120603
EMDN description: CANNULATED SCREWS
First on market country: -
Authorised representative: ICON (LR) Limited
Last updated: 16.07.2026 06:47

Manufacturer products Authorised representative products Authorised representative actors View details

00810055520091

Class IIbMDR 2017/745On the marketImplantableSingle useSterileSutures

Manufacturer: SI-BONE, Inc.
Manufacturer SRN: US-MF-000028624
UDI-DI: 00810055520091
Basic UDI-DI: 081005552torqimplantFN
Reference: 10065T
EMDN: P09120603
EMDN description: CANNULATED SCREWS
First on market country: -
Authorised representative: ICON (LR) Limited
Last updated: 16.07.2026 06:47

Manufacturer products Authorised representative products Authorised representative actors View details