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BlueDot Gastritis IgG

BlueDot Gastritis

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680469
Basic UDI-DI: 542502368BDGASTRITISLY
Reference: IFPCAD-24
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

Manufacturer products View details

BlueDot Celiac IgA

BlueDot Celiac

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680421
Basic UDI-DI: 542502368BDCELIACE4
Reference: ENDA-24
EMDN: W0102100602
EMDN description: TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

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BlueDot Cytoplasm6 IgG

BlueDot

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680407
Basic UDI-DI: 542502368BDCYTOPLASMUE
Reference: CY6D-24
EMDN: W0102100108
EMDN description: JO-1
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

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BlueDot APS IgG

BlueDot APS

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680360
Basic UDI-DI: 542502368BDAPS2U
Reference: APSGD-24
EMDN: W0102100599
EMDN description: ANTI-PHOSPHOLIP SYNDROME - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

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BlueDot ANA8 IgG

BlueDot

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680308
Basic UDI-DI: 542502368BDANAZF
Reference: ANA8D-24
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

Manufacturer products View details

BlueDot ANCA+GBM IgG

BlueDot ANCA+GBM

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680353
Basic UDI-DI: 542502368BDANCAYR
Reference: ANCAGD-24
EMDN: W0102100401
EMDN description: ANCA SCREENING
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

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SpermMar Test IgG antiserum

SPMG_S

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

Manufacturer: FertiPro
Manufacturer SRN: BE-MF-000000313
UDI-DI: 05411967002542
Basic UDI-DI: 5411967SPMGS135
Reference: SPMG_A
EMDN: W0102109013
EMDN description: SPERM ANTIBODIES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:59

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SpermMar Test IgA Single kit

SPMA_S

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: FertiPro
Manufacturer SRN: BE-MF-000000313
UDI-DI: 05411967002566
Basic UDI-DI: 5411967SPMAS127
Reference: SPMA_S
EMDN: W0102109013
EMDN description: SPERM ANTIBODIES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:52

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SpermMar Test IgG Complete kit

SPMG_C

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: FertiPro
Manufacturer SRN: BE-MF-000000313
UDI-DI: 05411967001354
Basic UDI-DI: 5411967SPMGC1ZJ
Reference: SPMG_C
EMDN: W0102109013
EMDN description: SPERM ANTIBODIES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:51

Manufacturer products View details

SpermMar Test IgA Complete kit

SPMA_C

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testing

Manufacturer: FertiPro
Manufacturer SRN: BE-MF-000000313
UDI-DI: 05411967001347
Basic UDI-DI: 5411967SPMAC1YL
Reference: SPMA_C
EMDN: W0102109013
EMDN description: SPERM ANTIBODIES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:51

Manufacturer products View details

SpermMar Test IgG Single kit

SPMG_S

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: FertiPro
Manufacturer SRN: BE-MF-000000313
UDI-DI: 05411967000036
Basic UDI-DI: 5411967SPMGS135
Reference: SPMG_S
EMDN: W0102109013
EMDN description: SPERM ANTIBODIES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:51

Manufacturer products View details

MESACUP TypeVII Collagen TEST

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.
Manufacturer SRN: JP-MF-000017864
UDI-DI: 04987506018448
Basic UDI-DI: 498750601844KG
Reference: 7846E
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 07:34

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Integrin αvβ6 ELISA Kit (IVD)

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.
Manufacturer SRN: JP-MF-000017864
UDI-DI: 04987506018417
Basic UDI-DI: 498750601841KA
Reference: 7670E
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 07:34

Manufacturer products Authorised representative products Authorised representative actors View details

04987506016833

MESACUP-2 TEST Desmoglein 3

IVD Class BIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.
Manufacturer SRN: JP-MF-000017864
UDI-DI: 04987506016833
Basic UDI-DI: 498750601683KG
Reference: 7886E
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 07:34

Manufacturer products Authorised representative products Authorised representative actors View details

04987506016826

MESACUP-2 TEST Desmoglein 1

IVD Class BIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.
Manufacturer SRN: JP-MF-000017864
UDI-DI: 04987506016826
Basic UDI-DI: 498750601682KE
Reference: 7881E
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 07:34

Manufacturer products Authorised representative products Authorised representative actors View details

04987506016819

MESACUP BP180 TEST

IVD Class BIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.
Manufacturer SRN: JP-MF-000017864
UDI-DI: 04987506016819
Basic UDI-DI: 498750601681KC
Reference: 7697E
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 07:34

Manufacturer products Authorised representative products Authorised representative actors View details

04987506016802

MESACUP BP230 TEST

IVD Class BIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.
Manufacturer SRN: JP-MF-000017864
UDI-DI: 04987506016802
Basic UDI-DI: 498750601680KA
Reference: 7614E
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 07:34

Manufacturer products Authorised representative products Authorised representative actors View details

B·R·A·H·M·S anti-TPOn KRYPTOR

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

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157632172
Basic UDI-DI: 426015763852BantTPOnKXX2Q
Reference: 852075N
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:34

Manufacturer products View details

B·R·A·H·M·S anti-Tgn KRYPTOR

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

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157632097
Basic UDI-DI: 426015763830BantiTgnKXXEH
Reference: 830075N
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:34

Manufacturer products View details

B·R·A·H·M·S TRAK human KRYPTOR

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

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157631823
Basic UDI-DI: 426015763801BTRAKhumKXXMX
Reference: 801050N
EMDN: W0102100302
EMDN description: TSH RECEPTOR ANTIBODIES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:33

Manufacturer products View details