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EUDAMED Device Search

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

TREN

Last updated

01.08.2026 13:11

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Device

2989326

Actor

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Certificate

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Active filter:EMDN:Z12120199

415 device results listed.

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08809240011058

PRK-5000, PRK-6000, PRK-7000, PRK-8000

Class IMDR 2017/745On the marketActive deviceMeasuring function
Manufacturer
POTEC Co., Ltd.
Manufacturer SRN
KR-MF-000012281
UDI-DI
08809240011058
Basic UDI-DI
880924001PRKNW
Reference
PRK-5000
EMDN
Z12120199
EMDN description
OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country
Germany
Authorised representative
MDSS GmbH
Last updated
01.08.2026 00:01
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Fundus Viewing System

600B

Class IMDR 2017/745On the marketDirect markingSingle use
Manufacturer
Shanghai Mediworks Precision Instruments Co., Ltd.
Manufacturer SRN
CN-MF-000004251
UDI-DI
06945087500286
Basic UDI-DI
69450875600BLE
Reference
600B
EMDN
Z12120199
EMDN description
OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country
Austria
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
31.07.2026 20:04
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Stereoptic Inverter

600A

Class IMDR 2017/745On the marketDirect markingSingle use
Manufacturer
Shanghai Mediworks Precision Instruments Co., Ltd.
Manufacturer SRN
CN-MF-000004251
UDI-DI
06945087500279
Basic UDI-DI
69450875600ALC
Reference
600A
EMDN
Z12120199
EMDN description
OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country
Austria
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
31.07.2026 20:04
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Amsler Chart (Pad of 50)

Amsler Grid

Class IMDR 2017/745On the marketDirect marking
Manufacturer
Keeler Ltd
Manufacturer SRN
GB-MF-000009031
UDI-DI
05055272706773
Basic UDI-DI
50552727AmslerGridH7
Reference
2215-P-7057
EMDN
Z12120199
EMDN description
OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country
Netherlands
Authorised representative
Keeler Europe Distribution, S.L.
Last updated
31.07.2026 08:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Peter Rabbit Test

Vision testing/training chart

Class IMDR 2017/745On the marketDirect marking
Manufacturer
Keeler Ltd
Manufacturer SRN
GB-MF-000009031
UDI-DI
05055272720885
Basic UDI-DI
50552727VisionTestChartA3
Reference
2205-L-1004
EMDN
Z12120199
EMDN description
OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country
Greece
Authorised representative
Keeler Europe Distribution, S.L.
Last updated
31.07.2026 08:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
POCKET SET 2.8V

Ophthalmic/otologic diagnostic set

Class IMDR 2017/745On the marketDirect marking
Manufacturer
Keeler Ltd
Manufacturer SRN
GB-MF-000009031
UDI-DI
05055272700641
Basic UDI-DI
5055272745084XR
Reference
1102-P-1041
EMDN
Z12120199
EMDN description
OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country
Italy
Authorised representative
Keeler Europe Distribution, S.L.
Last updated
31.07.2026 08:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
REFRACTIVE POWER/CORNEAL ANALYZER OPD-Scan III

OPD-Scan III

Class IIaMDR 2017/745On the marketActive deviceMeasuring function
Manufacturer
NIDEK.CO.Ltd.,
Manufacturer SRN
JP-MF-000040151
UDI-DI
04987669100776
Basic UDI-DI
4987669208GG
Reference
B01E009
EMDN
Z12120199
EMDN description
OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country
Northern Ireland
Authorised representative
NIDEK SA
Last updated
31.07.2026 07:42
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Non-Mydriatic Auto Fundus Camera AFC-330

AFC-330

Class IIaMDR 2017/745On the marketActive device
Manufacturer
NIDEK.CO.Ltd.,
Manufacturer SRN
JP-MF-000040151
UDI-DI
04987669100554
Basic UDI-DI
4987669213G9
Reference
15411-0E00,15411-00B0
EMDN
Z12120199
EMDN description
OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country
France
Authorised representative
NIDEK SA
Last updated
31.07.2026 07:42
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Optical Coherence Tomography RS-3000 Advance

RS-1,Mirante,RS-3000 Advance

Class IIaMDR 2017/745On the marketActive device
Manufacturer
NIDEK.CO.Ltd.,
Manufacturer SRN
JP-MF-000040151
UDI-DI
04987669100516
Basic UDI-DI
4987669216GF
Reference
10703-0050, 10703-02B0
EMDN
Z12120199
EMDN description
OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country
Germany
Authorised representative
NIDEK SA
Last updated
31.07.2026 07:42
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
MiiS Horus Scope

DSC series

Class IMDR 2017/745On the marketActive deviceDirect marking
Manufacturer
Medimaging Integrated Solution Inc
Manufacturer SRN
TW-MF-000009317
UDI-DI
04719872710066
Basic UDI-DI
47198727100007L
Reference
MiiS Horus Scope DSC 300
EMDN
Z12120199
EMDN description
OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country
Spain
Authorised representative
MedNet EC-REP GmbH
Last updated
31.07.2026 07:01
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
MiiS Horus Scope

DEA 100, DGC 200

Class IMDR 2017/745On the marketDirect marking
Manufacturer
Medimaging Integrated Solution Inc
Manufacturer SRN
TW-MF-000009317
UDI-DI
04719872711056
Basic UDI-DI
47198727110027X
Reference
MiiS Horus+ Scope DGC 200
EMDN
Z12120199
EMDN description
OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country
France
Authorised representative
MedNet EC-REP GmbH
Last updated
31.07.2026 06:44
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
MiiS Horus Scope

DEC series, EEC series

Class IMDR 2017/745On the marketDirect marking
Manufacturer
Medimaging Integrated Solution Inc
Manufacturer SRN
TW-MF-000009317
UDI-DI
04719872711032
Basic UDI-DI
47198727110007T
Reference
MiiS Horus Scope EEC 100
EMDN
Z12120199
EMDN description
OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country
France
Authorised representative
MedNet EC-REP GmbH
Last updated
31.07.2026 06:44
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
MiiS Horus Scope

DSC series

Class IMDR 2017/745On the marketActive deviceDirect marking
Manufacturer
Medimaging Integrated Solution Inc
Manufacturer SRN
TW-MF-000009317
UDI-DI
04719872710028
Basic UDI-DI
47198727100007L
Reference
MiiS Horus+ Scope DSC 200
EMDN
Z12120199
EMDN description
OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country
France
Authorised representative
MedNet EC-REP GmbH
Last updated
31.07.2026 06:44
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
MiiS Horus Scope

DEA 100, DGC 200

Class IMDR 2017/745On the marketDirect marking
Manufacturer
Medimaging Integrated Solution Inc
Manufacturer SRN
TW-MF-000009317
UDI-DI
04719872711025
Basic UDI-DI
47198727110027X
Reference
MiiS Horus Scope DEA 100
EMDN
Z12120199
EMDN description
OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country
France
Authorised representative
MedNet EC-REP GmbH
Last updated
31.07.2026 06:35
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
MiiS Horus Scope

DEC series, EEC series

Class IMDR 2017/745On the marketDirect marking
Manufacturer
Medimaging Integrated Solution Inc
Manufacturer SRN
TW-MF-000009317
UDI-DI
04719872711018
Basic UDI-DI
47198727110007T
Reference
MiiS Horus Scope DEC 100
EMDN
Z12120199
EMDN description
OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country
France
Authorised representative
MedNet EC-REP GmbH
Last updated
31.07.2026 06:35
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
VISUCORE 500 System

000000-2548-409

Class IIaMDR 2017/745On the market
Manufacturer
Carl Zeiss Vision GmbH
Manufacturer SRN
DE-PR-000040411
UDI-DI
04250668607219
Basic UDI-DI
42506686-B01-VCR500S-5K
Reference
000000-2548-409
EMDN
Z12120199
EMDN description
OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country
-
Authorised representative
-
Last updated
31.07.2026 00:43
Manufacturer productsView details
VISUREF 600

000000-2572-424

Class IIaMDR 2017/745On the marketActive deviceMeasuring function
Manufacturer
Carl Zeiss Vision GmbH
Manufacturer SRN
DE-MF-000006173
UDI-DI
04250668607202
Basic UDI-DI
42506686-B01-VR600-87
Reference
000000-2572-424
EMDN
Z12120199
EMDN description
OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country
Germany
Authorised representative
-
Last updated
31.07.2026 00:43
Manufacturer productsView details
VISUCORE 500 Refractor

000000-2522-537

Class IIaMDR 2017/745On the marketActive deviceMeasuring function
Manufacturer
Carl Zeiss Vision GmbH
Manufacturer SRN
DE-MF-000006173
UDI-DI
04250668606052
Basic UDI-DI
42506686-B01-VCR500R-5G
Reference
000000-2522-537
EMDN
Z12120199
EMDN description
OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country
Germany
Authorised representative
-
Last updated
31.07.2026 00:43
Manufacturer productsView details