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Alinity

IVD Class CIVDR 2017/746Not intended for EU marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740165574
Basic UDI-DI: 038074AIP0832LA
Reference: 08P3274
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 02:51

Manufacturer products View details

Alinity

IVD Class CIVDR 2017/746Not intended for EU marketHuman tissuesKitProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740177720
Basic UDI-DI: 038074AIP0948LW
Reference: 09P4819
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 02:51

Manufacturer products View details

mAlb Fast Test Kit (Immunofluorescence Assay)

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414737127
Basic UDI-DI: 695441470209H8
Reference: IF4009
EMDN: W0102010309
EMDN description: ALBUMIN (IC) INCL. UALBUMIN
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 22.09.2026 02:49

Manufacturer products Authorised representative products Authorised representative actors View details

mAlb Fast Test Kit (Immunofluorescence Assay)

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414738636
Basic UDI-DI: 695441470209H8
Reference: IF4009
EMDN: W0102010309
EMDN description: ALBUMIN (IC) INCL. UALBUMIN
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 22.09.2026 02:49

Manufacturer products Authorised representative products Authorised representative actors View details

IDK® ß-Glucuronidase Aktivität

IDK® beta-Glucuronidase Aktivität

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598009264
Basic UDI-DI: B-04050598009264
Reference: K 6991
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 02:46

Manufacturer products View details

LyoSens™

VDDOA20

IVD Class BIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548251688
Basic UDI-DI: 868499827PCR02XD
Reference: LYO02WS48
EMDN: W0102160502
EMDN description: AMPHETAMINE/METHAMPHETAMINE SPECIFIC (+ECSTASY) - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 02:45

Manufacturer products View details

CEA Rapid Test Cassette

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-TCE-R402EW
Basic UDI-DI: B-TCE-R402EW
Reference: TCE-R402
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 22.09.2026 02:44

Manufacturer products Authorised representative products Authorised representative actors View details

FOB Rapid Test (Faeces)

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983125765
Basic UDI-DI: B-06936983125765
Reference: TFO-601H
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.09.2026 02:43

Manufacturer products Authorised representative products Authorised representative actors View details

06936983155229

CA125 Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983155229
Basic UDI-DI: B-06936983155229
Reference: T125-402
EMDN: W0102030106
EMDN description: CANCER ANTIGEN 125
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.09.2026 02:42

Manufacturer products Authorised representative products Authorised representative actors View details

06936983155212

CA15-3 Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983155212
Basic UDI-DI: B-06936983155212
Reference: T153-402
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.09.2026 02:42

Manufacturer products Authorised representative products Authorised representative actors View details

06936983123099

CA19-9 Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983123099
Basic UDI-DI: B-06936983123099
Reference: T199-402
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.09.2026 02:42

Manufacturer products Authorised representative products Authorised representative actors View details

KEYU Giardia lamblia Antigen Test Kit (Colloidal Gold Method)

GL-I

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735361849
Basic UDI-DI: B-06974735361849
Reference: GL-I
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 22.09.2026 02:34

Manufacturer products Authorised representative products Authorised representative actors View details

FOB Fast Test Kit (Immunofluorescence Assay)

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414757538
Basic UDI-DI: 695441470234H7
Reference: IF4042
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 22.09.2026 02:34

Manufacturer products Authorised representative products Authorised representative actors View details

FOB Fast Test Kit (Immunofluorescence Assay)

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414757521
Basic UDI-DI: 695441470234H7
Reference: IF2042
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 22.09.2026 02:34

Manufacturer products Authorised representative products Authorised representative actors View details

mAlb Fast Test Kit (Immunofluorescence Assay)

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414757545
Basic UDI-DI: 695441470209H8
Reference: IF2009
EMDN: W0102010309
EMDN description: ALBUMIN (IC) INCL. UALBUMIN
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 22.09.2026 02:34

Manufacturer products Authorised representative products Authorised representative actors View details

ARCHITECT

IVD Class CIVDR 2017/746Not intended for EU marketAnimal tissuesKitProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740172930
Basic UDI-DI: 038074ARL0353N2
Reference: 03L5309
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 02:30

Manufacturer products View details

ARCHITECT

IVD Class CIVDR 2017/746Not intended for EU marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740174828
Basic UDI-DI: 038074ARD0818KZ
Reference: 08D1819
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 02:30

Manufacturer products View details

Alinity

IVD Class CIVDR 2017/746Not intended for EU marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740168193
Basic UDI-DI: 038074AIP0940LE
Reference: 09P4074
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 02:30

Manufacturer products View details

Alinity

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740189822
Basic UDI-DI: 038074AIP0926LL
Reference: 09P2602
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 02:30

Manufacturer products View details

ARCHITECT

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740156527
Basic UDI-DI: 038074ARL0171MS
Reference: 01L7127
EMDN: W0102152204
EMDN description: CARDIAC MARKER STANDARDS AND CALIBRATORS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 02:30

Manufacturer products View details