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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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Google Irregular Rhythm Notifications

FB604

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Fitbit LLC
Manufacturer SRN: US-MF-000007439
UDI-DI: 00810028737778
Basic UDI-DI: 081003885FB604RA
Reference: GA13099
EMDN: Z12050382
EMDN description: ELECTROCARDIOGRAPHS - SOFTWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 03:36

Manufacturer products Authorised representative products Authorised representative actors View details

Julius Wirth

Dental Device

Class IMDR 2017/745On the market

Manufacturer: J&J Instruments, LLC
Manufacturer SRN: US-MF-000008974
UDI-DI: 00810036783675
Basic UDI-DI: 08100367812235EC
Reference: 735-001
EMDN: L010103
EMDN description: HANDLES FOR SCALPELS, REUSABLE
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 03:29

Manufacturer products Authorised representative products Authorised representative actors View details

Julius Wirth

Dental Device

Class IMDR 2017/745On the market

Manufacturer: J&J Instruments, LLC
Manufacturer SRN: US-MF-000008974
UDI-DI: 00810036783484
Basic UDI-DI: 08100367816197FR
Reference: 728-001
EMDN: L150201
EMDN description: DENTAL RETRACTORS, REUSABLE
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 03:29

Manufacturer products Authorised representative products Authorised representative actors View details

Julius Wirth

Dental Device

Class IMDR 2017/745On the marketReusable

Manufacturer: J&J Instruments, LLC
Manufacturer SRN: US-MF-000008974
UDI-DI: 00810036781152
Basic UDI-DI: 08100367815713FG
Reference: 704-001
EMDN: L150302
EMDN description: DENTAL RONGEURS, REUSABLE
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 03:29

Manufacturer products Authorised representative products Authorised representative actors View details

Julius Wirth

Dental Device

Class IMDR 2017/745On the marketReusable

Manufacturer: J&J Instruments, LLC
Manufacturer SRN: US-MF-000008974
UDI-DI: 00810036780896
Basic UDI-DI: 08100367812726F4
Reference: 703-001
EMDN: L0205
EMDN description: NEEDLE HOLDERS, REUSABLE
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 03:29

Manufacturer products Authorised representative products Authorised representative actors View details

Julius Wirth

Dental Device

Class IMDR 2017/745On the market

Manufacturer: J&J Instruments, LLC
Manufacturer SRN: US-MF-000008974
UDI-DI: 00810036780254
Basic UDI-DI: 08100367815712FE
Reference: 206-003
EMDN: Q01010199
EMDN description: DENTAL RESTORATION DEVICES - OTHER
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 03:29

Manufacturer products Authorised representative products Authorised representative actors View details

00810021438979

DCI II Manual Control Unit for 2HP, 1 Wet & 1 Dry

Class IMDR 2017/745On the marketActive device

Manufacturer: DCI International, LLC
Manufacturer SRN: US-MF-000022306
UDI-DI: 00810021438979
Basic UDI-DI: 081002143UNITSZ8
Reference: 4102
EMDN: Z12110101
EMDN description: DENTAL TREATMENT UNITS
First on market country: Belgium
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 03:28

Manufacturer products Authorised representative products Authorised representative actors View details

00810021436951

LIGHT

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: DCI International, LLC
Manufacturer SRN: US-MF-000022306
UDI-DI: 00810021436951
Basic UDI-DI: 081002143lightKD
Reference: LIGHT
EMDN: Z12010701
EMDN description: FIXED SCIALYTIC LAMPS
First on market country: France
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 03:28

Manufacturer products Authorised representative products Authorised representative actors View details

00810021431147

HVESE

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: DCI International, LLC
Manufacturer SRN: US-MF-000022306
UDI-DI: 00810021431147
Basic UDI-DI: 081002143HVESEUW
Reference: HVESE
EMDN: Q019001
EMDN description: SALIVA ASPIRATORS AND SALIVA ABSORBENTS
First on market country: France
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 03:28

Manufacturer products Authorised representative products Authorised representative actors View details

Access 1000 Medical Exam Table

Class IMDR 2017/745On the marketDirect marking

Manufacturer: The Brewer Company LLC
Manufacturer SRN: US-MF-000037766
UDI-DI: 00728564010005
Basic UDI-DI: 07285641000NF
Reference: 1000
EMDN: V080202
EMDN description: MANUAL MEDICAL CHAIRS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 02:56

Manufacturer products Authorised representative products Authorised representative actors View details

GAIT TRAINER III, 230V

GAIT TRAINER

Class IMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Biodex Medical Systems
Manufacturer SRN: US-MF-000028834
UDI-DI: 00718175005415
Basic UDI-DI: 071817521759
Reference: 950-401
EMDN: Z129006
EMDN description: TREADMILLS FOR PHYSIOTHERAPY AND/OR DIAGNOSTIC USES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 02:44

Manufacturer products Authorised representative products Authorised representative actors View details

NxSTEP UNWEIGHING SYSTEM w/o HARNESS

Offset Unweighing System

Class IMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Biodex Medical Systems
Manufacturer SRN: US-MF-000028834
UDI-DI: 00718175004845
Basic UDI-DI: 071817521657
Reference: 950-484
EMDN: Y050201
EMDN description: STANDING SUPPORT GAIT TRAINERS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 02:44

Manufacturer products Authorised representative products Authorised representative actors View details

NxStep Unweighing System

Class IMDR 2017/745On the marketActive device

Manufacturer: Sport Medical Technology Inc
Manufacturer SRN: US-MF-000051649
UDI-DI: 00718175004807
Basic UDI-DI: 0718175216UWDQ
Reference: 950-480
EMDN: Y050201
EMDN description: STANDING SUPPORT GAIT TRAINERS
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 02:44

Manufacturer products Authorised representative products Authorised representative actors View details

System 4 Pro

Biodex System 4

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Biodex Medical Systems
Manufacturer SRN: US-MF-000028834
UDI-DI: 00718175004005
Basic UDI-DI: 07181752014S
Reference: 850-000
EMDN: Z12062680
EMDN description: DYNAMOMETRIC SYSTEMS FOR MOVEMENT ANALYSIS - HARDWARE
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 02:43

Manufacturer products Authorised representative products Authorised representative actors View details

BALANCE SYSTEM SD 230V

Balance System

Class IMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Biodex Medical Systems
Manufacturer SRN: US-MF-000028834
UDI-DI: 00718175000045
Basic UDI-DI: 07181752095A
Reference: 950-441
EMDN: Z12140404
EMDN description: POSTUROGRAPHY SYSTEMS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 02:43

Manufacturer products Authorised representative products Authorised representative actors View details

iReceptal® Digital Surgical Suction System

iRS302

Class IIaMDR 2017/745On the marketActive deviceReusable

Manufacturer: Amsino International Inc.
Manufacturer SRN: US-MF-000007234
UDI-DI: 40704411017760
Basic UDI-DI: 0704411490ZC
Reference: iRS302
EMDN: A06030499
EMDN description: INTRA-OPERATION FLUID COLLECTION DEVICES - OTHER
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 01:21

Manufacturer products Authorised representative products Authorised representative actors View details

AMSure® Bulb Irrigation Syringe

Irrigation Syringe

Class IMDR 2017/745On the marketSingle use

Manufacturer: Amsino International Inc.
Manufacturer SRN: US-MF-000007234
UDI-DI: 40704411008447
Basic UDI-DI: 0704411328Z2
Reference: AS010
EMDN: A020102010202
EMDN description: INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 01:21

Manufacturer products Authorised representative products Authorised representative actors View details

AMSure® Specimen Container

Specimen Container

Class IMDR 2017/745On the marketSingle use

Manufacturer: Amsino International Inc.
Manufacturer SRN: US-MF-000007234
UDI-DI: 40704411008409
Basic UDI-DI: 0704411320YJ
Reference: AS343
EMDN: W05010203
EMDN description: URINE COLLECTION, CONTAINERS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 01:21

Manufacturer products Authorised representative products Authorised representative actors View details

AMSure® EAR/ULCER SYRINGE

Ear/Ulcer Syringe

Class IMDR 2017/745On the marketSingle use

Manufacturer: Amsino International Inc.
Manufacturer SRN: US-MF-000007234
UDI-DI: 40704411008317
Basic UDI-DI: 0704411404YR
Reference: AS00501
EMDN: A06010103
EMDN description: CANNULAS AND TIPS FOR ASPIRATION AND IRRIGATION, SINGLE-USE
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 01:21

Manufacturer products Authorised representative products Authorised representative actors View details

Suction Canister

Canister

Class IMDR 2017/745On the marketMeasuring functionSingle use

Manufacturer: Amsino International Inc.
Manufacturer SRN: US-MF-000007234
UDI-DI: 30704411005920
Basic UDI-DI: 0704411453Z6
Reference: WFM1200D
EMDN: A06030401
EMDN description: INTRAOPERATIVE SUCTION CONTAINERS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 01:21

Manufacturer products Authorised representative products Authorised representative actors View details