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IVD generalIVDDNo longer on the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587602332
Basic UDI-DI: B-06419587602332
Reference: 602330
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 03.08.2026 03:54

Manufacturer products View details

i-ImmunDx™ Analyzer

S03A

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

Manufacturer: Seinda Biomedical Corporation
Manufacturer SRN: CN-MF-000047055
UDI-DI: 06972976460031
Basic UDI-DI: 697297646S03VG
Reference: S03A-004
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.08.2026 14:08

Manufacturer products Authorised representative products Authorised representative actors View details

FIAPro™ Mini Immunofluorescence Analyzer

VMFIA1006

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

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595032251
Basic UDI-DI: 868459503FIAProMiniR3
Reference: VMFIA1006
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 02.08.2026 14:00

Manufacturer products View details

06914329008637

IVD self-testing devicesNot specifiedNo longer on the market

Manufacturer: Beijing Yicheng Bioelectronics Technology Co., Ltd.
Manufacturer SRN: CN-MF-000033130
UDI-DI: 06914329008637
Basic UDI-DI: B-06914329008637
Reference: Model 5DT-4： 112010013
EMDN: W0201069092
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: -
Authorised representative: Caretechion GmbH
Last updated: 01.08.2026 17:12

Manufacturer products Authorised representative products Authorised representative actors View details

06914329008781

IVD self-testing devicesNot specifiedNo longer on the market

Manufacturer: Beijing Yicheng Bioelectronics Technology Co., Ltd.
Manufacturer SRN: CN-MF-000033130
UDI-DI: 06914329008781
Basic UDI-DI: B-06914329008781
Reference: 113080006
EMDN: W0201069092
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: -
Authorised representative: Caretechion GmbH
Last updated: 01.08.2026 17:12

Manufacturer products Authorised representative products Authorised representative actors View details

06914329008842

IVD self-testing devicesNot specifiedNo longer on the market

Manufacturer: Beijing Yicheng Bioelectronics Technology Co., Ltd.
Manufacturer SRN: CN-MF-000033130
UDI-DI: 06914329008842
Basic UDI-DI: B-06914329008842
Reference: System（Model T-1）：114010011
EMDN: W0201069092
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: -
Authorised representative: Caretechion GmbH
Last updated: 01.08.2026 17:12

Manufacturer products Authorised representative products Authorised representative actors View details

Micro Heater Incubator

VMFIA1006

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

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595032268
Basic UDI-DI: 868459503MH57
Reference: VMH1001
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 23:28

Manufacturer products View details

Mini Immunofluorescence Analyzer

OG-H101

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

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173654708
Basic UDI-DI: 81649002OG-H10189
Reference: OG-H101
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: 31.07.2026 22:19

Manufacturer products Authorised representative products Authorised representative actors View details

Multiplex Fluorescent Analyzer

OG-G260

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

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173653022
Basic UDI-DI: 81017365OG-G2604E
Reference: OG-G260
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: 31.07.2026 22:19

Manufacturer products Authorised representative products Authorised representative actors View details

Multi-function analyzer (blood glucose, uric acid, lipids, blood pressure)

IVD Class ANot specifiedNo longer on the market

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: 06971771200194
Basic UDI-DI: 69717712001948N
Reference: GULP-101
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 21:21

Manufacturer products Authorised representative products Authorised representative actors View details

06936983171526

Uric Acid Meter

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

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983171526
Basic UDI-DI: 6970277510020LYB
Reference: AUAR-100
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:12

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Glucose/ Ketone/ Uric Acid/ Total Cholesterol 4 in 1 monitoring system II

Instrument

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

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983164825
Basic UDI-DI: 6970277510019RZD
Reference: AGKUCR-200
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:12

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Glucose/ Ketone/ Uric Acid/ Total Cholesterol 4 in 1 monitoring system I

Instrument

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

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983164795
Basic UDI-DI: 6970277510019QZB
Reference: AGKUCR-100
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:12

Manufacturer products Authorised representative products Authorised representative actors View details

FIA Analyzer FLI-100

FLI-100

IVD Class AIVDR 2017/746No longer on the marketInstrumentKitProfessional testing

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260209064
Basic UDI-DI: 69332602IT01000029T
Reference: BT0106
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

FIA Analyzer BIOT-YG-I

BIOT-YG-I

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testing

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260209088
Basic UDI-DI: 69332602IT01000049X
Reference: BT0104
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

06925912711063

UNICELL-S

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912711063
Basic UDI-DI: 692591270143H8
Reference: F6101
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Greece
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

06925912711056

I-UNICELL

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912711056
Basic UDI-DI: 692591270146HE
Reference: I6101
EMDN: W0201069080
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Cyprus
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

Colloidal Gold Immunoassay Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963722973
Basic UDI-DI: 692196372294JJ
Reference: CG-300
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 31.07.2026 18:12

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence Immunoassay Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963719669
Basic UDI-DI: 692196371965K7
Reference: QDS-300A
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 31.07.2026 18:12

Manufacturer products Authorised representative products Authorised representative actors View details

Labmaster LUCIA™ Analyzer

LM26

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

Manufacturer: Labmaster Oy
Manufacturer SRN: FI-MF-000023942
UDI-DI: 06429810777003
Basic UDI-DI: 6429810777LM268N
Reference: LM26
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:45

Manufacturer products View details