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D-ECH01010564W

Cystatin C (Cys C)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01010564W
Basic UDI-DI: B-ECH01010564W
Reference: ECH0101056
EMDN: W0102019008
EMDN description: CYSTATIN C
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:33

Manufacturer products Authorised representative products Authorised representative actors View details

Cystatin C Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-CYS-C601K6
Basic UDI-DI: B-CYS-C601K6
Reference: CYS-C6011Y, CYS-C6012Y, CYS-C6013Y, CYS-C6014Y, CYS-C6015Y, CYS-C6011N, CYS-C6012N, CYS-C6013N, CYS-C6014N, CYS-C6015N
EMDN: W0102019008
EMDN description: CYSTATIN C
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 13:39

Manufacturer products Authorised representative products Authorised representative actors View details

D-CQ5771023F

HISCL β-Amyloid 1-42 Assay kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: D-CQ5771023F
Basic UDI-DI: B-CQ5771023F
Reference: CQ577102
EMDN: W0102019014
EMDN description: BETA-AMYLOID (1-42)
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 13.07.2026 07:20

Manufacturer products Authorised representative products Authorised representative actors View details

D-BV4191423U

HISCL β-Amyloid 1-40 Assay kit

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: D-BV4191423U
Basic UDI-DI: B-BV4191423U
Reference: BV419142
EMDN: W0102019013
EMDN description: BETA-AMYLOID (1-40)
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 13.07.2026 03:30

Manufacturer products Authorised representative products Authorised representative actors View details

D-BL170013UX

HISCL β-Amyloid 1-40 Calibrator

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: D-BL170013UX
Basic UDI-DI: B-BL170013UX
Reference: BL170013
EMDN: W0102019013
EMDN description: BETA-AMYLOID (1-40)
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 13.07.2026 03:27

Manufacturer products Authorised representative products Authorised representative actors View details

D-AT130265

N/A

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.
Manufacturer SRN: AT-MF-000000254
UDI-DI: D-AT130265
Basic UDI-DI: B-AT130265
Reference: AT1302
EMDN: W0102019001
EMDN description: A1-ACID GLYCOPROTEIN (OROSOMUCOID)
First on market country: Austria
Authorised representative: -
Last updated: 12.07.2026 21:44

Manufacturer products View details

Adenosine Deaminase Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-ADA6014B
Basic UDI-DI: B-ADA6014B
Reference: ADA6011Y, ADA6012Y, ADA6013Y, ADA6014Y, ADA6015Y, ADA6011N, ADA6012N, ADA6013N, ADA6014N, ADA6015N
EMDN: W0102019010
EMDN description: ADENOSINE DEAMINASE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 21:28

Manufacturer products Authorised representative products Authorised representative actors View details

D-AA1002X2

N/A

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.
Manufacturer SRN: AT-MF-000000254
UDI-DI: D-AA1002X2
Basic UDI-DI: B-AA1002X2
Reference: AA1002
EMDN: W0102019001
EMDN description: A1-ACID GLYCOPROTEIN (OROSOMUCOID)
First on market country: Austria
Authorised representative: -
Last updated: 12.07.2026 21:16

Manufacturer products View details

IMMAGE Immunochemistry Systems CCRP High Sensitivity Cardiac CRP Reagent

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-A38656VR
Basic UDI-DI: B-A38656VR
Reference: A38656
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

D-A0702911HWB

N/A

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.
Manufacturer SRN: AT-MF-000000254
UDI-DI: D-A0702911HWB
Basic UDI-DI: B-A0702911HWB
Reference: A0702911H
EMDN: W0102019001
EMDN description: A1-ACID GLYCOPROTEIN (OROSOMUCOID)
First on market country: Austria
Authorised representative: -
Last updated: 12.07.2026 21:15

Manufacturer products View details

D-A06842H89

N/A

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.
Manufacturer SRN: AT-MF-000000254
UDI-DI: D-A06842H89
Basic UDI-DI: B-A06842H89
Reference: A06842H
EMDN: W0102019001
EMDN description: A1-ACID GLYCOPROTEIN (OROSOMUCOID)
First on market country: Austria
Authorised representative: -
Last updated: 12.07.2026 21:15

Manufacturer products View details

D-A06602H77

N/A

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.
Manufacturer SRN: AT-MF-000000254
UDI-DI: D-A06602H77
Basic UDI-DI: B-A06602H77
Reference: A06602H
EMDN: W0102019001
EMDN description: A1-ACID GLYCOPROTEIN (OROSOMUCOID)
First on market country: Austria
Authorised representative: -
Last updated: 12.07.2026 21:15

Manufacturer products View details

INDICAID™ Calprotectin/Lactoferrin Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A008CX
Basic UDI-DI: B-A008CX
Reference: INDICAID™ Calprotectin/Lactoferrin Rapid Test
EMDN: W0102019009
EMDN description: CALPROTECTIN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 21:14

Manufacturer products Authorised representative products Authorised representative actors View details

D-A00502S4

N/A

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.
Manufacturer SRN: AT-MF-000000254
UDI-DI: D-A00502S4
Basic UDI-DI: B-A00502S4
Reference: A00502
EMDN: W0102019001
EMDN description: A1-ACID GLYCOPROTEIN (OROSOMUCOID)
First on market country: Austria
Authorised representative: -
Last updated: 12.07.2026 21:14

Manufacturer products View details

CRP Test

800034-x

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: D-880034R8
Basic UDI-DI: B-880034R8
Reference: 880034-1
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Czechia
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

Dr Max

IVD self-testing devicesNot specifiedOn the marketSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: D-880034-1BG
Basic UDI-DI: B-880034-1BG
Reference: 880034-1CRS
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Czechia
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

α1-Antitrypsin

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060313275090
Basic UDI-DI: B-86060313275090
Reference: C1821ATR
EMDN: W0102019002
EMDN description: A1-ANTITRYPSIN (PROTEASE INHIBITOR)
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 12.07.2026 10:14

Manufacturer products Authorised representative products Authorised representative actors View details

Alfa 1 Glycoprotein Antibody

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: MTD Diagnostics srl
Manufacturer SRN: IT-MF-000053242
UDI-DI: 8053617720115ZJ
Basic UDI-DI: B-8053617720115ZJ
Reference: TB1083
EMDN: W0102019001
EMDN description: A1-ACID GLYCOPROTEIN (OROSOMUCOID)
First on market country: Italy
Authorised representative: -
Last updated: 12.07.2026 09:32

Manufacturer products View details

PRIMA HOME TEST

800034-x

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: D-800034-1CS3S
Basic UDI-DI: B-800034-1CS3S
Reference: 800034-1CS
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Czechia
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 09:29

Manufacturer products Authorised representative products Authorised representative actors View details

Cystatin C (CYS-C) Assay Kit (Immunoturbidimetric Method)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: YHLO BIOTECH (NANJING) CO., LTD.
Manufacturer SRN: CN-MF-000050474
UDI-DI: D-77H50TSCW5
Basic UDI-DI: B-77H50TSCW5
Reference: 77H50TSC
EMDN: W0102019008
EMDN description: CYSTATIN C
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 09:25

Manufacturer products Authorised representative products Authorised representative actors View details