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TEST KASETİ-1 (62’LİK)

CST06-01

IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595039380
Basic UDI-DI: 868459503CST06NV
Reference: CST06
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 18:38

Manufacturer products View details

FIAPro™ Mobile Immunofluorescence Analyzer

VMFIA1003

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsInstrumentNear-patient testingProfessional testing

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548252623
Basic UDI-DI: 868354825FIAProMobilXJ
Reference: VMFIA1003
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 03.07.2026 18:14

Manufacturer products View details

iREAD

Qassay Lateral Flow Reader DUAL

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: P4Q Health S.L.U.
Manufacturer SRN: ES-MF-000039526
UDI-DI: 08445982000037
Basic UDI-DI: 8445982Q1A-DUO-USBZM
Reference: IR-786
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:28

Manufacturer products View details

Qassay Lateral Flow Reader Visible

Q1A-VIS-USB

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: P4Q Health S.L.U.
Manufacturer SRN: ES-MF-000039526
UDI-DI: 08445982000051
Basic UDI-DI: 8445982Q1A-VIS-USB7S
Reference: Q1A-VIS-USB
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:28

Manufacturer products View details

Hand-Held Immunofluorescence

OG-G300

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

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00816490028444
Basic UDI-DI: 81649002OG-G3008A
Reference: OG-G300
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-G200

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

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00816490028437
Basic UDI-DI: 81649002OG-G20085
Reference: OG-G200
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

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

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

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