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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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472 device results listed.

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00860009458109

Sentinel

IVD Class AIVDR 2017/746On the marketHuman tissuesInstrument

Manufacturer: VistaPath Biosystems, Inc.
Manufacturer SRN: US-MF-000039863
UDI-DI: 00860009458109
Basic UDI-DI: 08600094581173
Reference: Sentinel V1
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Northern Ireland
Authorised representative: Qualrep Services B.V.
Last updated: 16.07.2026 06:52

Manufacturer products Authorised representative products Authorised representative actors View details

HYDROS TRUS Probe

HU1000

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: PROCEPT BioRobotics Corporation
Manufacturer SRN: US-MF-000015560
UDI-DI: 00850055427075
Basic UDI-DI: 0850055427HU1000NX
Reference: HU1000
EMDN: Z1104020201
EMDN description: ENDOCAVITARY ULTRASOUND PROBES, TWO–DIMENSIONAL
First on market country: Netherlands
Authorised representative: Qualrep Services B.V.
Last updated: 16.07.2026 06:30

Manufacturer products Authorised representative products Authorised representative actors View details

HYDROS Robotic System

HY1000

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: PROCEPT BioRobotics Corporation
Manufacturer SRN: US-MF-000015560
UDI-DI: 00850055427068
Basic UDI-DI: 0850055427HY1000QB
Reference: HY1000
EMDN: Z120106
EMDN description: HYDRODISSECTORS
First on market country: Netherlands
Authorised representative: Qualrep Services B.V.
Last updated: 16.07.2026 06:30

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HYDROS Handpiece

HH1000

Class IIaMDR 2017/745On the marketActive deviceCMR substanceSingle useSterile

Manufacturer: PROCEPT BioRobotics Corporation
Manufacturer SRN: US-MF-000015560
UDI-DI: 00850055427051
Basic UDI-DI: 0850055427HH1000JG
Reference: HH1000
EMDN: Z120106
EMDN description: HYDRODISSECTORS
First on market country: Netherlands
Authorised representative: Qualrep Services B.V.
Last updated: 16.07.2026 06:30

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Lithotomy Drape

351101

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: PROCEPT BioRobotics Corporation
Manufacturer SRN: US-MF-000015560
UDI-DI: 00850055427044
Basic UDI-DI: 08500554273511014D
Reference: 351101
EMDN: T020199
EMDN description: SURGICAL DRAPES - OTHER
First on market country: Netherlands
Authorised representative: Qualrep Services B.V.
Last updated: 16.07.2026 06:30

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AquaBeam Robotic System

AB2000

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: PROCEPT BioRobotics Corporation
Manufacturer SRN: US-MF-000015560
UDI-DI: 00850055427020
Basic UDI-DI: 0850055427AB2000DS
Reference: AB2000
EMDN: Z120106
EMDN description: HYDRODISSECTORS
First on market country: Netherlands
Authorised representative: Qualrep Services B.V.
Last updated: 16.07.2026 06:30

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AquaBeam Scope

SC2000

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: PROCEPT BioRobotics Corporation
Manufacturer SRN: US-MF-000015560
UDI-DI: 00850055427013
Basic UDI-DI: 0850055427SC2000MF
Reference: SC2000
EMDN: Z12020701
EMDN description: CYSTOSCOPES
First on market country: Netherlands
Authorised representative: Qualrep Services B.V.
Last updated: 16.07.2026 06:30

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AquaBeam Handpiece

HP2000

Class IIaMDR 2017/745On the marketActive deviceCMR substanceSingle useSterile

Manufacturer: PROCEPT BioRobotics Corporation
Manufacturer SRN: US-MF-000015560
UDI-DI: 00850055427006
Basic UDI-DI: 0850055427HP2000MF
Reference: HP2000
EMDN: Z120106
EMDN description: HYDRODISSECTORS
First on market country: Netherlands
Authorised representative: Qualrep Services B.V.
Last updated: 16.07.2026 06:30

Manufacturer products Authorised representative products Authorised representative actors View details

Typesafe 2.0

4R4750

IVD Class AIVDR 2017/746On the marketInstrumentSingle use

Manufacturer: Typenex Medical, LLC
Manufacturer SRN: US-MF-000024001
UDI-DI: 10812269031254
Basic UDI-DI: 081226903BDABBSUU
Reference: SP0201QM
EMDN: W02079003
EMDN description: DISPENSERS
First on market country: Poland
Authorised representative: Qualrep Services B.V.
Last updated: 16.07.2026 04:13

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Zeos

Light Guide and Adapter

Class IMDR 2017/745On the marketDirect markingReusable

Manufacturer: Santa Barbara Imaging Systems, Inc.
Manufacturer SRN: US-MF-000007262
UDI-DI: 00853460007153
Basic UDI-DI: 0812231038X-20-XXXXXF
Reference: 84-20-5004
EMDN: Z12020480
EMDN description: INSTRUMENTS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES - HARDWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: Qualrep Services B.V.
Last updated: 16.07.2026 04:13

Manufacturer products Authorised representative products Authorised representative actors View details

Pixa

4K HDR Camera System

Class IMDR 2017/745On the marketActive device

Manufacturer: Santa Barbara Imaging Systems, Inc.
Manufacturer SRN: US-MF-000007262
UDI-DI: 00812231033821
Basic UDI-DI: 0812231038X-10-XXXXWW
Reference: 85-10-5001
EMDN: Z12020401
EMDN description: INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES
First on market country: France
Authorised representative: Qualrep Services B.V.
Last updated: 16.07.2026 04:11

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Smearsafe

BD0101

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testingSingle use

Manufacturer: Typenex Medical, LLC
Manufacturer SRN: US-MF-000024001
UDI-DI: 20810050855796
Basic UDI-DI: 081005085BDABCTP7
Reference: BD0101
EMDN: W02079003
EMDN description: DISPENSERS
First on market country: Italy
Authorised representative: Qualrep Services B.V.
Last updated: 16.07.2026 03:44

Manufacturer products Authorised representative products Authorised representative actors View details

10810050854211

7000E

Class IMDR 2017/745On the marketSingle use

Manufacturer: Typenex Medical, LLC
Manufacturer SRN: US-MF-000024001
UDI-DI: 10810050854211
Basic UDI-DI: 081005085EMEBAGTD
Reference: 8000E
EMDN: A060301
EMDN description: COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE
First on market country: Iceland
Authorised representative: Qualrep Services B.V.
Last updated: 16.07.2026 03:44

Manufacturer products Authorised representative products Authorised representative actors View details

Annalise Container

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Harrison-AI Medical Pty Ltd
Manufacturer SRN: AU-MF-000010247
UDI-DI: G140ANNALISECONTAINER40
Basic UDI-DI: ++G140ANNALISECONTAINERR9
Reference: Annalisecontainer4
EMDN: Z11030582
EMDN description: RADIOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: Qualrep Services B.V.
Last updated: 15.07.2026 19:35

Manufacturer products Authorised representative products Authorised representative actors View details

Annalise Web Viewer

Class IMDR 2017/745On the marketActive device

Manufacturer: Harrison-AI Medical Pty Ltd
Manufacturer SRN: AU-MF-000010247
UDI-DI: G140ANNALISEWEBVIEWER20
Basic UDI-DI: ++G140WebViewer72
Reference: ANNALISEWEBVIEWER2
EMDN: Z11030582
EMDN description: RADIOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Denmark
Authorised representative: Qualrep Services B.V.
Last updated: 15.07.2026 19:35

Manufacturer products Authorised representative products Authorised representative actors View details

Annalise Enterprise

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Harrison-AI Medical Pty Ltd
Manufacturer SRN: AU-MF-000010247
UDI-DI: G140ANNALISEENTP30
Basic UDI-DI: ++G140AnnaliseEnterprisEM
Reference: AnnaliseENTP3
EMDN: Z11030582
EMDN description: RADIOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Spain
Authorised representative: Qualrep Services B.V.
Last updated: 15.07.2026 19:35

Manufacturer products Authorised representative products Authorised representative actors View details

iCLAS™ Shaped Stylet Accesory

FULL COIL FLUTTER

Class IMDDNo longer on the marketSingle useSterile

Manufacturer: Adagio Medical, Inc.
Manufacturer SRN: US-MF-000001129
UDI-DI: D-109-0014-023SW
Basic UDI-DI: B-109-0014-023SW
Reference: 109-0014-023
EMDN: C020380
EMDN description: ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES
First on market country: Belgium
Authorised representative: Qualrep Services B.V.
Last updated: 11.07.2026 05:44

Manufacturer products Authorised representative products Authorised representative actors View details

iCLAS™ Shaped Stylet Accesory

C-SHAPED FLUTTER

Class IMDDNo longer on the marketSingle useSterile

Manufacturer: Adagio Medical, Inc.
Manufacturer SRN: US-MF-000001129
UDI-DI: D-109-0014-022SU
Basic UDI-DI: B-109-0014-022SU
Reference: 109-0014-022
EMDN: C020380
EMDN description: ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES
First on market country: Belgium
Authorised representative: Qualrep Services B.V.
Last updated: 11.07.2026 05:44

Manufacturer products Authorised representative products Authorised representative actors View details

iCLAS™ Shaped Stylet Accesory

STRAIGHT FLUTTER

Class IMDDNo longer on the marketSingle useSterile

Manufacturer: Adagio Medical, Inc.
Manufacturer SRN: US-MF-000001129
UDI-DI: D-109-0014-021SS
Basic UDI-DI: B-109-0014-021SS
Reference: 109-0014-021
EMDN: C020380
EMDN description: ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES
First on market country: Belgium
Authorised representative: Qualrep Services B.V.
Last updated: 11.07.2026 05:44

Manufacturer products Authorised representative products Authorised representative actors View details

iCLAS™ Shaped Stylet Accesory

FOCAL STRAIGHT 10-20-10

Class IMDDNo longer on the marketSingle useSterile

Manufacturer: Adagio Medical, Inc.
Manufacturer SRN: US-MF-000001129
UDI-DI: D-109-0014-020SQ
Basic UDI-DI: B-109-0014-020SQ
Reference: 109-0014-020
EMDN: C020380
EMDN description: ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES
First on market country: Belgium
Authorised representative: Qualrep Services B.V.
Last updated: 11.07.2026 05:44

Manufacturer products Authorised representative products Authorised representative actors View details