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α1-Microglobulin Assay Kit (Latex Immunoturbidimetric Method)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-11L82
Basic UDI-DI: B-11L82
Reference: /
EMDN: W0102019004
EMDN description: A1-MICROGLOBULIN
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 05:52

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A Test Kit (CLIA)

Serum Amyloid A Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: 10850076346123
Basic UDI-DI: B-10850076346123
Reference: CDSAA-401a
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 04:36

Manufacturer products Authorised representative products Authorised representative actors View details

Heparin-Binding Protein Test Kit (CLIA)

Heparin-Binding Protein Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: 10850076346116
Basic UDI-DI: B-10850076346116
Reference: CDHBP-301a
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 04:36

Manufacturer products Authorised representative products Authorised representative actors View details

VEUPLEX™ TBI assay

EZ-TBIV

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: EzDiaTech, Inc.
Manufacturer SRN: KR-MF-000026926
UDI-DI: 08809901510067
Basic UDI-DI: B-08809901510067
Reference: EZ-TBIV
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.07.2026 17:01

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays α2-Macroglobulin (Immunoturbidimetric)

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145588779
Basic UDI-DI: 69471455641WK
Reference: 130503013A
EMDN: W0102019003
EMDN description: A2-MACROGLOBULIN
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 10.07.2026 06:44

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays α2-Macroglobulin Calibrators

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145588793
Basic UDI-DI: 69471455641WK
Reference: 160202641CS
EMDN: W0102019003
EMDN description: A2-MACROGLOBULIN
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 10.07.2026 06:44

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays α2-Macroglobulin Calibrators

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145588809
Basic UDI-DI: 69471455641WK
Reference: 160202641CU
EMDN: W0102019003
EMDN description: A2-MACROGLOBULIN
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 10.07.2026 06:44

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays α2-Macroglobulin Controls

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145588816
Basic UDI-DI: 69471455641WK
Reference: 160202641QS
EMDN: W0102019003
EMDN description: A2-MACROGLOBULIN
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 10.07.2026 06:44

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays α2-Macroglobulin Controls

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145588823
Basic UDI-DI: 69471455641WK
Reference: 160202641QU
EMDN: W0102019003
EMDN description: A2-MACROGLOBULIN
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 10.07.2026 06:44

Manufacturer products Authorised representative products Authorised representative actors View details

SimplexTAS 101 CRP Reagent Cartridge

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: tascom co., ltd.
Manufacturer SRN: KR-MF-000019000
UDI-DI: 08800037900852
Basic UDI-DI: B-08800037900852
Reference: T0101022
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 00:06

Manufacturer products Authorised representative products Authorised representative actors View details

RapidFor™ Calprotectin (50µg/g+ 200µg/g) Test Kit

VMD137BC

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998279734
Basic UDI-DI: B-08684998279734
Reference: VMD137
EMDN: W0102019009
EMDN description: CALPROTECTIN
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:22

Manufacturer products View details

RapidFor™ Calprotectin (50µg/g+ 200µg/g) Test Kit

VMD137SD

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998279727
Basic UDI-DI: B-08684998279727
Reference: VMD137
EMDN: W0102019009
EMDN description: CALPROTECTIN
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:22

Manufacturer products View details

RapidFor™ Calprotectin Rapid Test Kit (FIA)

VMPO80

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595030189
Basic UDI-DI: B-08684595030189
Reference: VMPO80
EMDN: W0102019009
EMDN description: CALPROTECTIN
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:13

Manufacturer products View details

Adenosine Deaminase (ADA) Kit

Adenosine Deaminase (ADA) Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000040334
UDI-DI: 08683555623607
Basic UDI-DI: B-08683555623607
Reference: B27040
EMDN: W0102019010
EMDN description: ADENOSINE DEAMINASE
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 00:54

Manufacturer products View details

RapidFor™ Cystatin C Rapid Test Kit (FIA)

VMPO19

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548250308
Basic UDI-DI: B-08683548250308
Reference: VMPO19
EMDN: W0102019008
EMDN description: CYSTATIN C
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:09

Manufacturer products View details

ADA (ADENOZİN DEAMİNAZ)

ADA (ADENOSINE DEAMINASE) REAGENT

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000027166
UDI-DI: 08681812512190
Basic UDI-DI: B-08681812512190
Reference: T1011
EMDN: W0102019010
EMDN description: ADENOSINE DEAMINASE
First on market country: Türkiye
Authorised representative: -
Last updated: 08.07.2026 18:37

Manufacturer products View details

ADA (ADENOZİN DEAMİNAZ)

ADA (ADENOSINE DEAMINASE) REAGENT

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000027166
UDI-DI: 08681812508865
Basic UDI-DI: B-08681812508865
Reference: T1010
EMDN: W0102019010
EMDN description: ADENOSINE DEAMINASE
First on market country: Türkiye
Authorised representative: -
Last updated: 08.07.2026 18:37

Manufacturer products View details

alpha-1-ACID GLYCOPROTEIN

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287119282
Basic UDI-DI: B-08435287119282
Reference: 31928
EMDN: W0102019001
EMDN description: A1-ACID GLYCOPROTEIN (OROSOMUCOID)
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:47

Manufacturer products View details

QUANTA Flash® Calprotectin Reagents

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950907206
Basic UDI-DI: B-08426950907206
Reference: 701350
EMDN: W0102019009
EMDN description: CALPROTECTIN
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 23:22

Manufacturer products Authorised representative products Authorised representative actors View details

7797

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: GIESSE DIAGNOSTICS SRL
Manufacturer SRN: IT-MF-000039031
UDI-DI: 08053172971915
Basic UDI-DI: B-08053172971915
Reference: 7797
EMDN: W0102019008
EMDN description: CYSTATIN C
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 19:47

Manufacturer products View details