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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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00863604000032

Class IIIMDR 2017/745On the marketImplantableSingle useSterile

Manufacturer: SI-BONE, Inc.
Manufacturer SRN: US-MF-000028624
UDI-DI: 00863604000032
Basic UDI-DI: 081005552ifuseimplantV9
Reference: 107590-90
EMDN: P09070101
EMDN description: SPINAL CAGES
First on market country: -
Safety summary (SSCP/SSP): 301000 · Rev. F
Authorised representative: ICON (LR) Limited
Last updated: 02.08.2026 22:28

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

00865707000438

Class IIaNot specifiedOn the marketSingle useSterile

Manufacturer: EDGe Surgical, Inc
Manufacturer SRN: US-MF-000052496
UDI-DI: 00865707000438
Basic UDI-DI: B-00865707000438
Reference: 21342-65-01-10-LN
EMDN: Z12139085
EMDN description: VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - CONSUMABLES
First on market country: Greece
Authorised representative: ICON (LR) Limited
Last updated: 02.08.2026 22:28

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FARASTAR

FARASTAR Catheter Connection Cable

Class IIIMDDOn the marketSingle useSterile

Manufacturer: Farapulse Inc
Manufacturer SRN: US-MF-000017969
UDI-DI: 00810087180119
Basic UDI-DI: B-00810087180119
Reference: 41M404
EMDN: C020304
EMDN description: ARRHYTHMOGENIC FOCI PULSED FIELD ABLATION CATHETERS
First on market country: Netherlands
Authorised representative: ICON (LR) Limited
Last updated: 01.08.2026 10:39

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FARAWAVE™

FARAWAVE Pulsed Field Ablation Catheter, 35mm

Class IIIMDDOn the marketActive deviceAnimal tissuesSingle useSterile

Manufacturer: Farapulse Inc
Manufacturer SRN: US-MF-000017969
UDI-DI: 00810087180102
Basic UDI-DI: B-00810087180102
Reference: 41M402
EMDN: C020304
EMDN description: ARRHYTHMOGENIC FOCI PULSED FIELD ABLATION CATHETERS
First on market country: Netherlands
Authorised representative: ICON (LR) Limited
Last updated: 01.08.2026 10:39

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FARAWAVE™

FARAWAVE Pulsed Field Ablation Catheter, 31mm

Class IIIMDDOn the marketActive deviceAnimal tissuesSingle useSterile

Manufacturer: Farapulse Inc
Manufacturer SRN: US-MF-000017969
UDI-DI: 00810087180096
Basic UDI-DI: B-00810087180096
Reference: 41M401
EMDN: C020304
EMDN description: ARRHYTHMOGENIC FOCI PULSED FIELD ABLATION CATHETERS
First on market country: Netherlands
Authorised representative: ICON (LR) Limited
Last updated: 01.08.2026 10:39

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FARADRIVE™

FARADRIVE Steerable Sheath (clear)

Class IIIMDDOn the marketAnimal tissuesSingle useSterile

Manufacturer: Farapulse Inc
Manufacturer SRN: US-MF-000017969
UDI-DI: 00810087180072
Basic UDI-DI: B-00810087180072
Reference: 21M402
EMDN: C0502
EMDN description: CARDIOVASCULAR INTRODUCER SHEATHS, VALVED
First on market country: Netherlands
Authorised representative: ICON (LR) Limited
Last updated: 01.08.2026 10:39

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Paradise™

PRDS-USG-2X

Class IIbMDDOn the marketActive device

Manufacturer: ReCor Medical, Inc.
Manufacturer SRN: US-MF-000027816
UDI-DI: 00810008950128
Basic UDI-DI: B-00810008950128
Reference: PRDS-USG-2X
EMDN: Z129099
EMDN description: VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - OTHER
First on market country: Germany
Authorised representative: ICON (LR) Limited
Last updated: 01.08.2026 10:22

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Paradise™

PRDS-USG-2X

Class IIbMDDOn the marketActive device

Manufacturer: ReCor Medical, Inc.
Manufacturer SRN: US-MF-000027816
UDI-DI: 00810008950111
Basic UDI-DI: B-00810008950111
Reference: PRDS-USG-2X
EMDN: Z129099
EMDN description: VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - OTHER
First on market country: Germany
Authorised representative: ICON (LR) Limited
Last updated: 01.08.2026 10:22

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Paradise™

PRDS-CT-02

Class IMDDOn the marketSingle useSterile

Manufacturer: ReCor Medical, Inc.
Manufacturer SRN: US-MF-000027816
UDI-DI: 00810008950074
Basic UDI-DI: B-00810008950074
Reference: PRDS-CT-02
EMDN: K02050103
EMDN description: COMBINED RADIOFREQUENCY / ULTRASOUND SURGERY INSTRUMENT KITS, SINGLE-USE
First on market country: Germany
Authorised representative: ICON (LR) Limited
Last updated: 01.08.2026 10:22

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Paradise™

PRDS-063-02

Class IIbMDDOn the marketActive deviceSingle useSterile

Manufacturer: ReCor Medical, Inc.
Manufacturer SRN: US-MF-000027816
UDI-DI: 00810008950067
Basic UDI-DI: B-00810008950067
Reference: PRDS-063-02
EMDN: K02050109
EMDN description: COMBINED RADIOFREQUENCY / ULTRASONIC SURGERY HANDPIECES, SINGLE-USE
First on market country: Germany
Authorised representative: ICON (LR) Limited
Last updated: 01.08.2026 10:22

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Paradise™

PRDS-CC-02

Class IMDDOn the marketSingle useSterile

Manufacturer: ReCor Medical, Inc.
Manufacturer SRN: US-MF-000027816
UDI-DI: 00810008950050
Basic UDI-DI: B-00810008950050
Reference: PRDS-CC-02
EMDN: K02050103
EMDN description: COMBINED RADIOFREQUENCY / ULTRASOUND SURGERY INSTRUMENT KITS, SINGLE-USE
First on market country: Germany
Authorised representative: ICON (LR) Limited
Last updated: 01.08.2026 10:22

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Paradise™

PRDS-068-02

Class IIbMDDOn the marketActive deviceSingle useSterile

Manufacturer: ReCor Medical, Inc.
Manufacturer SRN: US-MF-000027816
UDI-DI: 00810008950043
Basic UDI-DI: B-00810008950043
Reference: PRDS-068-02
EMDN: K02050109
EMDN description: COMBINED RADIOFREQUENCY / ULTRASONIC SURGERY HANDPIECES, SINGLE-USE
First on market country: Germany
Authorised representative: ICON (LR) Limited
Last updated: 01.08.2026 10:22

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Paradise™

PRDS-067-02

Class IIbMDDOn the marketActive deviceSingle useSterile

Manufacturer: ReCor Medical, Inc.
Manufacturer SRN: US-MF-000027816
UDI-DI: 00810008950036
Basic UDI-DI: B-00810008950036
Reference: PRDS-067-02
EMDN: K02050109
EMDN description: COMBINED RADIOFREQUENCY / ULTRASONIC SURGERY HANDPIECES, SINGLE-USE
First on market country: Germany
Authorised representative: ICON (LR) Limited
Last updated: 01.08.2026 10:22

Manufacturer products Authorised representative products Authorised representative actors View details

Paradise™

PRDS-065-02

Class IIbMDDOn the marketActive deviceSingle useSterile

Manufacturer: ReCor Medical, Inc.
Manufacturer SRN: US-MF-000027816
UDI-DI: 00810008950012
Basic UDI-DI: B-00810008950012
Reference: PRDS-065-02
EMDN: K02050109
EMDN description: COMBINED RADIOFREQUENCY / ULTRASONIC SURGERY HANDPIECES, SINGLE-USE
First on market country: Germany
Authorised representative: ICON (LR) Limited
Last updated: 01.08.2026 10:22

Manufacturer products Authorised representative products Authorised representative actors View details

Paradise™

Class IIbNot specifiedOn the marketSingle useSterile

Manufacturer: ReCor Medical, Inc.
Manufacturer SRN: US-MF-000027816
UDI-DI: 00810008950005
Basic UDI-DI: B-00810008950005
Reference: PRDS-064-02
EMDN: K02050109
EMDN description: COMBINED RADIOFREQUENCY / ULTRASONIC SURGERY HANDPIECES, SINGLE-USE
First on market country: Germany
Authorised representative: ICON (LR) Limited
Last updated: 01.08.2026 10:22

Manufacturer products Authorised representative products Authorised representative actors View details

Prism

2386

Class IMDR 2017/745On the marketDirect marking

Manufacturer: North Coast Medical Inc.
Manufacturer SRN: US-MF-000009087
UDI-DI: 10768627002414
Basic UDI-DI: 0768627CSTACC-2386-SZ
Reference: NC12955-1
EMDN: M030504
EMDN description: IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES
First on market country: Finland
Authorised representative: ICON (LR) Limited
Last updated: 30.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

Omega Max

1027

Class IMDR 2017/745On the marketDirect marking

Manufacturer: North Coast Medical Inc.
Manufacturer SRN: US-MF-000009087
UDI-DI: 10768627002162
Basic UDI-DI: 0768627CSTACC-1027-R6
Reference: NC12796-1
EMDN: M030504
EMDN description: IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES
First on market country: Sweden
Authorised representative: ICON (LR) Limited
Last updated: 30.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

Preferred

1002

Class IMDR 2017/745On the marketDirect marking

Manufacturer: North Coast Medical Inc.
Manufacturer SRN: US-MF-000009087
UDI-DI: 10768627002100
Basic UDI-DI: 0768627CSTACC-1002-QD
Reference: NC12790-1
EMDN: M030504
EMDN description: IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES
First on market country: Ireland
Authorised representative: ICON (LR) Limited
Last updated: 30.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

00869826000393

Single-use drill bit

Class IIaMDR 2017/745On the marketDirect markingSingle use

Manufacturer: SI-BONE, Inc.
Manufacturer SRN: US-MF-000028624
UDI-DI: 00869826000393
Basic UDI-DI: 081005552Drillbit2T
Reference: 500254
EMDN: P091303
EMDN description: ORTHOPAEDIC IMPLANT DRILL BITS, SINGLE-USE
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

00869826000348

Chisel

Class IMDR 2017/745On the marketDirect markingReusable

Manufacturer: SI-BONE, Inc.
Manufacturer SRN: US-MF-000028624
UDI-DI: 00869826000348
Basic UDI-DI: 081005552ChiselLZ
Reference: 500262
EMDN: L0999
EMDN description: ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER
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