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A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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ORAgene Dx

ORAgene (Swab-based DNA & Dx Collection Device)

IVD Class AIVDR 2017/746On the marketKitSingle use

Manufacturer: DNA Genotek Inc.
Manufacturer SRN: CA-MF-000003486
UDI-DI: 00627595000224
Basic UDI-DI: 0627595A0100EF
Reference: OGD-575
EMDN: A1101
EMDN description: SAMPLE COLLECTION NEUTRAL SWABS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 01:05

Manufacturer products Authorised representative products Authorised representative actors View details

ORAgene Dx

ORAgene

IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: DNA Genotek Inc.
Manufacturer SRN: CA-MF-000003486
UDI-DI: 00627595000019
Basic UDI-DI: 0627595E0500GF
Reference: OGD-500
EMDN: W05019002
EMDN description: SALIVA COLLECTION DEVICES
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 01:05

Manufacturer products Authorised representative products Authorised representative actors View details

Intercept i2

3001-2661

IVD Class AIVDR 2017/746No longer on the marketDirect markingProfessional testingReagentSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 00608337001006
Basic UDI-DI: 0608337300126127F
Reference: 1001-0383
EMDN: W050180
EMDN description: SAMPLES COLLECTION DEVICES - OTHER ACCESSORIES
First on market country: Norway
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 00:53

Manufacturer products Authorised representative products Authorised representative actors View details

PRO-Diary Motion

PRO-Diary

Class IMDR 2017/745On the marketDirect marking

Manufacturer: CamNtech Ltd
Manufacturer SRN: GB-MF-000004683
UDI-DI: B329PDM25
Basic UDI-DI: ++B329PDM01XT
Reference: 05-111
EMDN: Z12040199
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - OTHER
First on market country: Denmark
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 14:53

Manufacturer products Authorised representative products Authorised representative actors View details

MotionWatch 8

MotionWatch

Class IMDR 2017/745On the marketDirect marking

Manufacturer: CamNtech Ltd
Manufacturer SRN: GB-MF-000004683
UDI-DI: B329MW850
Basic UDI-DI: ++B329MTN012J
Reference: 04-111
EMDN: Z12040199
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 14:53

Manufacturer products Authorised representative products Authorised representative actors View details

LED Worth Four Dot Test

Diplopia Tests

Class IMDR 2017/745On the market

Manufacturer: Gulden Ophthalmics
Manufacturer SRN: US-MF-000008608
UDI-DI: +B091153040W
Basic UDI-DI: ++B091DiplopiaTest5C
Reference: 15304
EMDN: Q0209
EMDN description: STRABISMUS DEVICES
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 14:47

Manufacturer products Authorised representative products Authorised representative actors View details

Color Fixation Sticks

Fixation Sticks

Class IMDR 2017/745On the market

Manufacturer: Gulden Ophthalmics
Manufacturer SRN: US-MF-000008608
UDI-DI: +B091151760$
Basic UDI-DI: ++B091FixationSticksGY
Reference: 15176
EMDN: Z129013
EMDN description: GENERAL AUDITORY AND/OR VISUAL STIMULATORS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 14:47

Manufacturer products Authorised representative products Authorised representative actors View details

Brock String

Cross Eye Convergence Trainer

Class IMDR 2017/745On the market

Manufacturer: Gulden Ophthalmics
Manufacturer SRN: US-MF-000008608
UDI-DI: +B091151330W
Basic UDI-DI: ++B091BrockStringHD
Reference: 15133
EMDN: Z12120201
EMDN description: CROSS–EYE CONVERGENCE TRAINERS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 14:47

Manufacturer products Authorised representative products Authorised representative actors View details

Large Neutral Density Bar

Neutral Density Filter Bar

Class IMDR 2017/745On the market

Manufacturer: Gulden Ophthalmics
Manufacturer SRN: US-MF-000008608
UDI-DI: +B091151170Y
Basic UDI-DI: ++B091NeutralDensityBar89
Reference: 15117
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 14:47

Manufacturer products Authorised representative products Authorised representative actors View details

Compact Magnetic Farnsworth Dichotomous D-15

Color Vision Tests

Class IMDR 2017/745On the market

Manufacturer: Gulden Ophthalmics
Manufacturer SRN: US-MF-000008608
UDI-DI: +B091151060W
Basic UDI-DI: ++B091D15KW
Reference: 15106
EMDN: Z1212012099
EMDN description: INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 14:47

Manufacturer products Authorised representative products Authorised representative actors View details

Red & Green Spectacles

Testing Glasses

Class IMDR 2017/745On the market

Manufacturer: Gulden Ophthalmics
Manufacturer SRN: US-MF-000008608
UDI-DI: +B091151050V
Basic UDI-DI: ++B091TestingGlassesKT
Reference: 15105
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 14:46

Manufacturer products Authorised representative products Authorised representative actors View details

Eye Shield, Adult (Bulk)

Eye Shields

Class IMDR 2017/745On the marketSingle use

Manufacturer: Gulden Ophthalmics
Manufacturer SRN: US-MF-000008608
UDI-DI: +B091141001Q
Basic UDI-DI: ++B091EyeShieldsZA
Reference: 14100
EMDN: M040399
EMDN description: OPHTHALMIC DRESSINGS - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 14:46

Manufacturer products Authorised representative products Authorised representative actors View details

Maddox Phoria Measure

Maddox Phoria

Class IMDR 2017/745On the market

Manufacturer: Gulden Ophthalmics
Manufacturer SRN: US-MF-000008608
UDI-DI: +B091121360W
Basic UDI-DI: ++B091MaddoxPhoriaSJ
Reference: 12136
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 14:46

Manufacturer products Authorised representative products Authorised representative actors View details

Ohlson Vital Stain Enhancement Filter

Filters

Class IMDR 2017/745On the market

Manufacturer: Gulden Ophthalmics
Manufacturer SRN: US-MF-000008608
UDI-DI: +B091121350V
Basic UDI-DI: ++B091FiltersXB
Reference: 12135
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 14:46

Manufacturer products Authorised representative products Authorised representative actors View details

Occluder Black Short

Occluders

Class IMDR 2017/745On the market

Manufacturer: Gulden Ophthalmics
Manufacturer SRN: US-MF-000008608
UDI-DI: +B091121100O
Basic UDI-DI: ++B091Occluders84
Reference: 12110
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 14:46

Manufacturer products Authorised representative products Authorised representative actors View details

Flipper 6 Holder

Lens Holder

Class IMDR 2017/745On the market

Manufacturer: Gulden Ophthalmics
Manufacturer SRN: US-MF-000008608
UDI-DI: +B091111220Q
Basic UDI-DI: ++B091LensHoldersC6
Reference: 11122
EMDN: Z1212012001
EMDN description: VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 14:46

Manufacturer products Authorised representative products Authorised representative actors View details

LB-14 Large Vertical Prism Bar

Prism Bar

Class IMDR 2017/745On the market

Manufacturer: Gulden Ophthalmics
Manufacturer SRN: US-MF-000008608
UDI-DI: +B091111110O
Basic UDI-DI: ++B091PrismBarsE2
Reference: 11111
EMDN: Z12120299
EMDN description: THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 14:46

Manufacturer products Authorised representative products Authorised representative actors View details

Vergence Facility Prism

Class IMDR 2017/745On the market

Manufacturer: Gulden Ophthalmics
Manufacturer SRN: US-MF-000008608
UDI-DI: +B091111070T
Basic UDI-DI: ++B091VergenceFacilityLR
Reference: 11107
EMDN: Z12120299
EMDN description: THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 14:46

Manufacturer products Authorised representative products Authorised representative actors View details

Single Prism - 1 Diopter

Prism

Class IMDR 2017/745On the market

Manufacturer: Gulden Ophthalmics
Manufacturer SRN: US-MF-000008608
UDI-DI: +B091111010O
Basic UDI-DI: ++B091PrismsTY
Reference: 11101-1
EMDN: Z12120299
EMDN description: THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 14:46

Manufacturer products Authorised representative products Authorised representative actors View details

D-W814JU

Finecare™ PSA Control

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: D-W814JU
Basic UDI-DI: B-W814JU
Reference: W814-L, W814-M, W814-H
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 13:29

Manufacturer products Authorised representative products Authorised representative actors View details