Public EUDAMED Search

EUDAMED Device Search

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

TR EN

Last updated

03.08.2026 10:01

Sync status

Successful

Device

2993907

Actor

47526

Certificate

3174

Filters

Show filters

Active filter:EMDN:W02010690

353 device results listed.

Page 11 / 18

CSV XML

Mini Immunofluorescence Analyzer

OG-H100

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00816490028420
Basic UDI-DI: 81649002OG-H10087
Reference: OG-H100
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.07.2026 12:44

Manufacturer products Authorised representative products Authorised representative actors View details

Immunofluorescence Analyzer

OG-H180

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00816490028192
Basic UDI-DI: 81649002OG-H1808X
Reference: OG-H180
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.07.2026 12:44

Manufacturer products Authorised representative products Authorised representative actors View details

Screen Box

SCREEN SMART

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: SCREEN ITALIA S.R.L.
Manufacturer SRN: IT-MF-000040460
UDI-DI: 08059015830869
Basic UDI-DI: 805901583READERDX
Reference: SC-0869-01
EMDN: W0201069082
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 12:17

Manufacturer products View details

80538418002324

NEMESYS

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testingSingle use

Manufacturer: A.S.T. s.r.l.
Manufacturer SRN: IT-MF-000029421
UDI-DI: 80538418002324
Basic UDI-DI: 805384180NEMESYSRS
Reference: NEMESYS SMART-POCT
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 09:57

Manufacturer products View details

Afinion 2

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: Abbott Diagnostics Technologies AS
Manufacturer SRN: NO-MF-000001423
UDI-DI: 07070060014418
Basic UDI-DI: 7070060AFI00013T
Reference: 1116770
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Norway
Authorised representative: -
Last updated: 03.07.2026 01:08

Manufacturer products View details

Dry Fluorescence Immunoassay Analyzer

FIC-S100

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: MaxBio (Tianjin) Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000048157
UDI-DI: 06978747210003
Basic UDI-DI: 697874721FIC-S1002M
Reference: FIC-S100
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: Kingsmead Service B.V.
Last updated: 03.07.2026 00:00

Manufacturer products Authorised representative products Authorised representative actors View details

Dry Fluorescence Immunoassay Analyzer

FIC-S100

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Rayce Biotechnology (Beijing) Co.,Ltd
Manufacturer SRN: CN-MF-000048156
UDI-DI: 06978735120000
Basic UDI-DI: 697873512FIC-S100X9
Reference: FIC-S100
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: Kingsmead Service B.V.
Last updated: 03.07.2026 00:00

Manufacturer products Authorised representative products Authorised representative actors View details

AllDx

M-HA

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: Hangzhou Aokai Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000048311
UDI-DI: 06978467910054
Basic UDI-DI: 697846791MHA000013R
Reference: M-HA-0014
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 02.07.2026 23:35

Manufacturer products Authorised representative products Authorised representative actors View details

AllDx

M-UA

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Aokai Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000048311
UDI-DI: 06978467910009
Basic UDI-DI: 697846791MUA00001AN
Reference: M-UA-0014
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 02.07.2026 23:35

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence Immunoassay Analyzer

AFE-101

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: 06978151200140
Basic UDI-DI: 697815120FIAAFE-101JQ
Reference: AFE-101
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 23:18

Manufacturer products Authorised representative products Authorised representative actors View details

Dry Fluorescence Immunoassay Analyzer

3000plus

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Coei Biotech Co.Ltd.
Manufacturer SRN: CN-MF-000049509
UDI-DI: 06977565589919
Basic UDI-DI: 6977565589952
Reference: 9912
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: France
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details

Colloidal Gold & Fluorescence Analyzer

3000multi

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Coei Biotech Co.Ltd.
Manufacturer SRN: CN-MF-000049509
UDI-DI: 06977565589810
Basic UDI-DI: 697756558984Y
Reference: 9812
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: France
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details

POCT Fully Immunofluorescence Quantitative Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Infitek Co., Ltd.
Manufacturer SRN: CN-MF-000040107
UDI-DI: 06975488440027
Basic UDI-DI: 697548844POC22TE
Reference: IFA-Q-1000
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 19:07

Manufacturer products Authorised representative products Authorised representative actors View details

Dry Biochemistry Immunoassay Analyzer

NIR-2000C

IVD Class AIVDR 2017/746Not intended for EU marketCompanion diagnosticsInstrumentProfessional testing

Manufacturer: WWHS Biotech.Inc
Manufacturer SRN: CN-MF-000027179
UDI-DI: 06975068491227
Basic UDI-DI: 6975068492040010U6
Reference: CP119.B1
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 18:03

Manufacturer products Authorised representative products Authorised representative actors View details

Consumable

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: Nanjing Poclight Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000039609
UDI-DI: 06974524062315
Basic UDI-DI: 697452406UZ4E
Reference: HCLIA1101A,HCLIA1101B
EMDN: W0201069085
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - CONSUMABLES
First on market country: Italy
Authorised representative: HUMISS TRADING S. L.
Last updated: 02.07.2026 16:26

Manufacturer products Authorised representative products Authorised representative actors View details

Chemiluminescence Immunoassay Analyzer

C5000

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Nanjing Poclight Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000039609
UDI-DI: 06974524061516
Basic UDI-DI: 697452406C50006A
Reference: PG1001
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: HUMISS TRADING S. L.
Last updated: 02.07.2026 16:26

Manufacturer products Authorised representative products Authorised representative actors View details

Immunofluorescence Analyzer

EASY-11

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521000068
Basic UDI-DI: 697452100SUPE011TN
Reference: SUPE01105
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 16:25

Manufacturer products Authorised representative products Authorised representative actors View details

Portable Incubator

EASY-1T

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521000105
Basic UDI-DI: 697452100SUPE01TVS
Reference: SUPE01T05
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 16:25

Manufacturer products Authorised representative products Authorised representative actors View details

Immunofluorescence Analyzer

DC903A

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Guangzhou Decheng Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000013536
UDI-DI: 06974464590589
Basic UDI-DI: 697446459903PP
Reference: DC903A
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 16:11

Manufacturer products Authorised representative products Authorised representative actors View details

Colloidal gold immunochromatography reader

GIC-S100、GIC-H1W、GIC-H1N、GIC-Q100、GIC-Q100N、GIC-M6、GIC-M6G、GIC-H2、GIC-A1600、GIC-H0、GIC-H0mini

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingInstrumentKitNear-patient testing

Manufacturer: Suzhou Helmen Precision Insturments Co.,Ltd
Manufacturer SRN: CN-MF-000002230
UDI-DI: 06973602150715
Basic UDI-DI: 697360215GICP5
Reference: GIC-H1N
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:48

Manufacturer products Authorised representative products Authorised representative actors View details