Public EUDAMED Search

EUDAMED Device Search

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

Last updated

22.09.2026 04:45

Sync status

Successful

Device

3513925

Actor

47688

Certificate

3340

Active filter:Manufacturer SRN:CN-MF-000002230

27 device results listed.

Page 1 / 2

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
Dry Fluorescence Immunoassay Analyzer

FIC-H1W、FIC-H1N、FIC-Q100、FIC-Q100N、FIC-H2、FIC-S100、FIC-A1600、FIC-M6、FIC-M6G、FIC-H0、FIC-H0mini、FIC-M2、FIC-M2NT

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingInstrumentNear-patient testingProfessional testing
Manufacturer
Suzhou Helmen Precision Insturments Co.,Ltd
Manufacturer SRN
CN-MF-000002230
UDI-DI
06973602150012
Basic UDI-DI
697360215FICNY
Reference
FIC-H1W
EMDN
W0201020201
EMDN description
IMMUNOCHEMISTRY READERS
First on market country
Germany
Authorised representative
Lotus NL B.V.
Last updated
02.07.2026 14:48
IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingInstrumentNear-patient testingProfessional testing
Manufacturer
Suzhou Helmen Precision Insturments Co.,Ltd
Manufacturer SRN
CN-MF-000002230
UDI-DI
06973602150029
Basic UDI-DI
697360215FICNY
Reference
FIC-H1N
EMDN
W0201020201
EMDN description
IMMUNOCHEMISTRY READERS
First on market country
-
Authorised representative
Lotus NL B.V.
Last updated
16.06.2026 13:19
IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingInstrumentNear-patient testingProfessional testing
Manufacturer
Suzhou Helmen Precision Insturments Co.,Ltd
Manufacturer SRN
CN-MF-000002230
UDI-DI
06973602150111
Basic UDI-DI
697360215FICNY
Reference
FIC-S100
EMDN
W0201020201
EMDN description
IMMUNOCHEMISTRY READERS
First on market country
-
Authorised representative
Lotus NL B.V.
Last updated
16.06.2026 13:19
IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingInstrumentNear-patient testingProfessional testing
Manufacturer
Suzhou Helmen Precision Insturments Co.,Ltd
Manufacturer SRN
CN-MF-000002230
UDI-DI
06973602150210
Basic UDI-DI
697360215FICNY
Reference
FIC-Q100N
EMDN
W0201020201
EMDN description
IMMUNOCHEMISTRY READERS
First on market country
-
Authorised representative
Lotus NL B.V.
Last updated
16.06.2026 13:19
IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingInstrumentNear-patient testingProfessional testing
Manufacturer
Suzhou Helmen Precision Insturments Co.,Ltd
Manufacturer SRN
CN-MF-000002230
UDI-DI
06973602150227
Basic UDI-DI
697360215FICNY
Reference
FIC-Q100
EMDN
W0201020201
EMDN description
IMMUNOCHEMISTRY READERS
First on market country
-
Authorised representative
Lotus NL B.V.
Last updated
16.06.2026 13:19
IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingInstrumentNear-patient testingProfessional testing
Manufacturer
Suzhou Helmen Precision Insturments Co.,Ltd
Manufacturer SRN
CN-MF-000002230
UDI-DI
06973602150319
Basic UDI-DI
697360215FICNY
Reference
FIC-M6
EMDN
W0201020201
EMDN description
IMMUNOCHEMISTRY READERS
First on market country
-
Authorised representative
Lotus NL B.V.
Last updated
16.06.2026 13:19
IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingInstrumentNear-patient testingProfessional testing
Manufacturer
Suzhou Helmen Precision Insturments Co.,Ltd
Manufacturer SRN
CN-MF-000002230
UDI-DI
06973602150326
Basic UDI-DI
697360215FICNY
Reference
FIC-M6G
EMDN
W0201020201
EMDN description
IMMUNOCHEMISTRY READERS
First on market country
-
Authorised representative
Lotus NL B.V.
Last updated
16.06.2026 13:19
IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingInstrumentNear-patient testingProfessional testing
Manufacturer
Suzhou Helmen Precision Insturments Co.,Ltd
Manufacturer SRN
CN-MF-000002230
UDI-DI
06973602150418
Basic UDI-DI
697360215FICNY
Reference
FIC-A1600
EMDN
W0201020201
EMDN description
IMMUNOCHEMISTRY READERS
First on market country
-
Authorised representative
Lotus NL B.V.
Last updated
16.06.2026 13:19
IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingInstrumentNear-patient testingProfessional testing
Manufacturer
Suzhou Helmen Precision Insturments Co.,Ltd
Manufacturer SRN
CN-MF-000002230
UDI-DI
06973602150517
Basic UDI-DI
697360215FICNY
Reference
FIC-H2
EMDN
W0201020201
EMDN description
IMMUNOCHEMISTRY READERS
First on market country
-
Authorised representative
Lotus NL B.V.
Last updated
16.06.2026 13:19
IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingInstrumentNear-patient testingProfessional testing
Manufacturer
Suzhou Helmen Precision Insturments Co.,Ltd
Manufacturer SRN
CN-MF-000002230
UDI-DI
06973602150616
Basic UDI-DI
697360215FICNY
Reference
FIC-H0mini
EMDN
W0201020201
EMDN description
IMMUNOCHEMISTRY READERS
First on market country
-
Authorised representative
Lotus NL B.V.
Last updated
16.06.2026 13:19
IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingInstrumentNear-patient testingProfessional testing
Manufacturer
Suzhou Helmen Precision Insturments Co.,Ltd
Manufacturer SRN
CN-MF-000002230
UDI-DI
06973602150623
Basic UDI-DI
697360215FICNY
Reference
FIC-H0
EMDN
W0201020201
EMDN description
IMMUNOCHEMISTRY READERS
First on market country
-
Authorised representative
Lotus NL B.V.
Last updated
16.06.2026 13:19
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
06973602150722
Basic UDI-DI
697360215GICP5
Reference
GIC-H1W
EMDN
W0201069099
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country
-
Authorised representative
Lotus NL B.V.
Last updated
16.06.2026 13:19
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
06973602150814
Basic UDI-DI
697360215GICP5
Reference
GIC-Q100
EMDN
W0201069099
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country
-
Authorised representative
Lotus NL B.V.
Last updated
16.06.2026 13:19
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
06973602150821
Basic UDI-DI
697360215GICP5
Reference
Colloidal gold immunochromatography reader
EMDN
W0201069099
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country
-
Authorised representative
Lotus NL B.V.
Last updated
16.06.2026 13:19
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
06973602150913
Basic UDI-DI
697360215GICP5
Reference
GIC-M6
EMDN
W0201069099
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country
-
Authorised representative
Lotus NL B.V.
Last updated
16.06.2026 13:19
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
06973602151019
Basic UDI-DI
697360215GICP5
Reference
GIC-A1600
EMDN
W0201069099
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country
-
Authorised representative
Lotus NL B.V.
Last updated
16.06.2026 13:19
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
06973602151118
Basic UDI-DI
697360215GICP5
Reference
GIC-H2
EMDN
W0201069099
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country
-
Authorised representative
Lotus NL B.V.
Last updated
16.06.2026 13:19