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

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Alinity

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

Manufacturer: Abbott Ireland Diagnostics Division
Manufacturer SRN: IE-MF-000010070
UDI-DI: 00380740186012
Basic UDI-DI: 038074AIP0813L6
Reference: 08P1327
EMDN: W0102152204
EMDN description: CARDIAC MARKER STANDARDS AND CALIBRATORS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 03:05

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ARCHITECT

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

Manufacturer: Abbott Ireland, Diagnostics Division
Manufacturer SRN: IE-MF-000009849
UDI-DI: 00380740195342
Basic UDI-DI: 038074XJT0001YP
Reference: 04W1801
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 03:05

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ARCHITECT

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

Manufacturer: Abbott Ireland, Diagnostics Division
Manufacturer SRN: IE-MF-000009849
UDI-DI: 00380740195359
Basic UDI-DI: 038074XJT0001YP
Reference: 04W1810
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 03:05

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Alinity

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

Manufacturer: Abbott Ireland, Diagnostics Division
Manufacturer SRN: IE-MF-000009849
UDI-DI: 00380740194888
Basic UDI-DI: 038074COI0001KS
Reference: 04W1910
EMDN: W01021701
EMDN description: GLIAL FIBRILLARY ACIDIC PROTEIN / UBIQUITIN C-TERMINAL HYDROLASE-L1
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 03:05

Manufacturer products 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: 06954414738421
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 03:02

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: 06954414738872
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 03:02

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: 06954414736670
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 03:02

Manufacturer products Authorised representative products Authorised representative actors View details

06976612386006

1gE 1 test/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Jinan Deheng Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000048173
UDI-DI: 06976612386006
Basic UDI-DI: B-06976612386006
Reference: IgE 1 test/kit
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 22.09.2026 02:59

Manufacturer products Authorised representative products Authorised representative actors 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: 00380740165598
Basic UDI-DI: 038074AIP0851LE
Reference: 08P5109
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 02:58

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Alinity

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

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740175665
Basic UDI-DI: 038074AIP0925LJ
Reference: 09P2577
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 02:58

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ARCHITECT

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

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740166076
Basic UDI-DI: 038074ARP0254PB
Reference: 02P5409
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 02:58

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ARCHITECT

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

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740201647
Basic UDI-DI: 038074ARP0520P9
Reference: 05P2074
EMDN: W0102152202
EMDN description: HORMONE STANDARDS AND CALIBRATORS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 02:58

Manufacturer products View details

ARCHITECT

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

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740174835
Basic UDI-DI: 038074ARK0841N9
Reference: 08K4109
EMDN: W0102152202
EMDN description: HORMONE STANDARDS AND CALIBRATORS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 02:58

Manufacturer products View details

Alinity

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

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740173234
Basic UDI-DI: 038074AIP0936LP
Reference: 09P3619
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 02:58

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: 00380740177713
Basic UDI-DI: 038074AIP0948LW
Reference: 09P4809
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 02:58

Manufacturer products View details

ARCHITECT

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740019648
Basic UDI-DI: 038074ARD0965LF
Reference: 09D6536
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 02:58

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: 00380740001742
Basic UDI-DI: 038074ARP0131NS
Reference: 01P3125
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 02:58

Manufacturer products View details

Alinity

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

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740174217
Basic UDI-DI: 038074AIT0475ML
Reference: 04T7509
EMDN: W0102152202
EMDN description: HORMONE STANDARDS AND CALIBRATORS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 02:58

Manufacturer products View details

Multi-Drug 10 Drugs Test Cassette(Oral Fluid)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06942598223789
Basic UDI-DI: B-06942598223789
Reference: DSD-8105-A
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.09.2026 02:57

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: 06954414753196
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 02:57

Manufacturer products Authorised representative products Authorised representative actors View details