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

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1.60UV

Class IMDR 2017/745On the market

Manufacturer: KOREA OPTICAL CO., LTD.
Manufacturer SRN: KR-MF-000008719
UDI-DI: 08808995100000
Basic UDI-DI: 880899510000ML
Reference: 1.60
EMDN: Q0210010101
EMDN description: MONOFOCAL ORGANIC OPHTHALMIC LENSES
First on market country: Austria
Authorised representative: KTR Europe GmbH
Last updated: 03.07.2026 20:44

Manufacturer products Authorised representative products Authorised representative actors View details

1.56UV420 BRC

Class IMDR 2017/745On the market

Manufacturer: KOREA OPTICAL CO., LTD.
Manufacturer SRN: KR-MF-000008719
UDI-DI: 08808995060007
Basic UDI-DI: 880899506000NK
Reference: 1.56UV420 BRC
EMDN: Q0210010101
EMDN description: MONOFOCAL ORGANIC OPHTHALMIC LENSES
First on market country: Austria
Authorised representative: KTR Europe GmbH
Last updated: 03.07.2026 20:44

Manufacturer products Authorised representative products Authorised representative actors View details

1.56

Class IMDR 2017/745On the market

Manufacturer: KOREA OPTICAL CO., LTD.
Manufacturer SRN: KR-MF-000008719
UDI-DI: 08808995040009
Basic UDI-DI: 880899504000N5
Reference: 1.56
EMDN: Q0210010101
EMDN description: MONOFOCAL ORGANIC OPHTHALMIC LENSES
First on market country: Austria
Authorised representative: KTR Europe GmbH
Last updated: 03.07.2026 20:44

Manufacturer products Authorised representative products Authorised representative actors View details

1.499

Class IMDR 2017/745On the market

Manufacturer: KOREA OPTICAL CO., LTD.
Manufacturer SRN: KR-MF-000008719
UDI-DI: 08808995000003
Basic UDI-DI: 880899500000M9
Reference: 1.499
EMDN: Q0210010101
EMDN description: MONOFOCAL ORGANIC OPHTHALMIC LENSES
First on market country: Austria
Authorised representative: KTR Europe GmbH
Last updated: 03.07.2026 20:44

Manufacturer products Authorised representative products Authorised representative actors View details

Da:all (P8B1950L-5070)

Sterile Absorbable Polydioxanone Suture with Needle, Dyed or Undyed

Class IIIMDR 2017/745No longer on the marketImplantableSingle useSterile

Manufacturer: META BIOMED CO., LTD.
Manufacturer SRN: KR-MF-000009681
UDI-DI: 08806387865568
Basic UDI-DI: 880638782001KS
Reference: -
EMDN: H0101010299
EMDN description: SYNTHETIC ABSORBABLE MULTIFILAMENT SUTURES - OTHER
First on market country: Germany
Safety summary (SSCP/SSP): BRD-18-17 · Rev. 3
Authorised representative: KTR Europe GmbH
Last updated: 03.07.2026 20:43

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

STAR RUCKUS

EMT-SR01;red

Class IMDR 2017/745On the marketActive device

Manufacturer: eMotiv Co., Ltd. MF
Manufacturer SRN: KR-MF-000055708
UDI-DI: 88009887200013
Basic UDI-DI: 880098872EMTSR014V
Reference: EMT-SR01;red
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Germany
Authorised representative: KTR Europe GmbH
Last updated: 03.07.2026 20:40

Manufacturer products Authorised representative products Authorised representative actors View details

18800118000010

DrNoon

Class IIaMDR 2017/745Not intended for EU marketActive deviceDirect marking

Manufacturer: Mediwhale, Inc
Manufacturer SRN: KR-MF-000011626
UDI-DI: 18800118000010
Basic UDI-DI: 88001180RetiAI68
Reference: IFU-DN-CE-05
EMDN: Z129092
EMDN description: VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - MEDICAL DEVICE SOFTWARE
First on market country: -
Authorised representative: KTR Europe GmbH
Last updated: 03.07.2026 20:39

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Scargel Auxilto

MCG12N

Class IMDR 2017/745Not intended for EU market

Manufacturer: Genewel Co., Ltd.
Manufacturer SRN: KR-MF-000009205
UDI-DI: 08806129671105
Basic UDI-DI: 880612960001F4
Reference: MCG12N
EMDN: M04041503
EMDN description: DRESSINGS IN SOLUTIONS, EMULSIONS, GELS, POWDERS WITH SYNTHETIC COMPONENTS
First on market country: -
Authorised representative: KTR Europe GmbH
Last updated: 03.07.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

MEDISTEP M Pro

Class IMDR 2017/745On the marketActive device

Manufacturer: Aitstudio CO., Ltd.
Manufacturer SRN: KR-MF-000051332
UDI-DI: 08800337580013
Basic UDI-DI: 880033758MEDISTEPMProJG
Reference: MEDISTEP
EMDN: Z12062592
EMDN description: KINEMATIC MOTION CAPTURE ANALYSIS SYSTEMS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: KTR Europe GmbH
Last updated: 03.07.2026 20:37

Manufacturer products Authorised representative products Authorised representative actors View details

vividbrain

NNS-VB(EU)

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Nunaps Inc.
Manufacturer SRN: KR-MF-000047455
UDI-DI: 08800255550037
Basic UDI-DI: 880025555NNS-VB(EU)XE
Reference: NNS-VB(EU)
EMDN: V92
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Germany
Authorised representative: KTR Europe GmbH
Last updated: 03.07.2026 20:36

Manufacturer products Authorised representative products Authorised representative actors View details

OK-Strips

OK-S, OK-P Series

Class IIaMDR 2017/745On the marketReusable

Manufacturer: Jaintek Co., Ltd.
Manufacturer SRN: KR-MF-000045113
UDI-DI: 08800115200218
Basic UDI-DI: 88001152S-0001U3
Reference: OKS1560/4
EMDN: Q010399
EMDN description: SURGICAL DENTAL DEVICES - OTHER
First on market country: Poland
Authorised representative: KTR Europe GmbH
Last updated: 03.07.2026 20:33

Manufacturer products Authorised representative products Authorised representative actors View details

OK-Handpiece

Low Speed Dental Handpiece, pneumatic

Class IIaMDR 2017/745On the marketActive deviceReusableSterile

Manufacturer: Jaintek Co., Ltd.
Manufacturer SRN: KR-MF-000045113
UDI-DI: 08800115200010
Basic UDI-DI: 88001152H-0001PL
Reference: OKH4
EMDN: Z12110199
EMDN description: INSTRUMENTS FOR DENTAL TREATMENT UNITS - OTHER
First on market country: Poland
Authorised representative: KTR Europe GmbH
Last updated: 03.07.2026 20:32

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Collection Tube Ⅱ

UC02-1

IVD Class AIVDR 2017/746On the marketKitReagentSingle use

Manufacturer: Genomictree, Inc.
Manufacturer SRN: KR-MF-000037890
UDI-DI: 18800076500515
Basic UDI-DI: 88000765UC02N2
Reference: UC02-1
EMDN: W05010202
EMDN description: URINE COLLECTION, TUBES
First on market country: Germany
Authorised representative: KTR Europe GmbH
Last updated: 03.07.2026 20:31

Manufacturer products Authorised representative products Authorised representative actors View details

GT NUCLEIC ACID PREP KIT

GT-PREP-1

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Genomictree, Inc.
Manufacturer SRN: KR-MF-000037890
UDI-DI: 18800076500461
Basic UDI-DI: 88000765PREP1PX
Reference: GT-PREP-1
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Germany
Authorised representative: KTR Europe GmbH
Last updated: 03.07.2026 20:31

Manufacturer products Authorised representative products Authorised representative actors View details

Stool Collection Kit Ⅲ

SC03-1

IVD Class AIVDR 2017/746On the marketKitReagentSingle use

Manufacturer: Genomictree, Inc.
Manufacturer SRN: KR-MF-000037890
UDI-DI: 18800076500447
Basic UDI-DI: 88000765SC03MN
Reference: SC03-1
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: Germany
Authorised representative: KTR Europe GmbH
Last updated: 03.07.2026 20:31

Manufacturer products Authorised representative products Authorised representative actors View details

Luvis Chair

LC700C

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: DENTIS CO., LTD
Manufacturer SRN: KR-MF-000012523
UDI-DI: 08800313232035
Basic UDI-DI: 88000530LC9N
Reference: LC700C
EMDN: Z12110101
EMDN description: DENTAL TREATMENT UNITS
First on market country: Germany
Authorised representative: KTR Europe GmbH
Last updated: 03.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

LUVIS

E100

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: DENTIS CO., LTD
Manufacturer SRN: KR-MF-000012523
UDI-DI: 08800266945068
Basic UDI-DI: 88000530E100BR
Reference: D-C-LVSL-V5-202602-ENG
EMDN: Z12010702
EMDN description: MOBILE SCIALYTIC LAMPS
First on market country: Poland
Authorised representative: KTR Europe GmbH
Last updated: 03.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

LUVIS

C500

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: DENTIS CO., LTD
Manufacturer SRN: KR-MF-000012523
UDI-DI: 08800266944375
Basic UDI-DI: 88000530C500BX
Reference: D-C-LVSL-V5-202602-ENG
EMDN: Q0199
EMDN description: ODONTOLOGY DEVICES - OTHER
First on market country: Poland
Authorised representative: KTR Europe GmbH
Last updated: 03.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

08800251000000

Zirtooth

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: HASS CORP.
Manufacturer SRN: KR-MF-000011621
UDI-DI: 08800251000000
Basic UDI-DI: 88000571TD701F2
Reference: Zirtooth H S-4019-H
EMDN: Q010699
EMDN description: MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER
First on market country: Germany
Authorised representative: KTR Europe GmbH
Last updated: 03.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

rebless

RHSW

Class IMDR 2017/745On the marketDirect marking

Manufacturer: H ROBOTICS INC.
Manufacturer SRN: KR-MF-000011627
UDI-DI: 08800101600015
Basic UDI-DI: 880010160RHSWAN
Reference: 2018
EMDN: Z12069099
EMDN description: VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: KTR Europe GmbH
Last updated: 03.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details