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14 device results listed.

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ReFiNE® Dkk3 ELISA

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598012714
Basic UDI-DI: 4050598DVPhysParaTV
Reference: Y1001
EMDN: W0102060299
EMDN description: RENAL METABOLISM TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 12.08.2026 23:20

Manufacturer products View details

VIDAS® NEPHROCLEAR™ CCL14

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026623418
Basic UDI-DI: 357302BUDI000908U7
Reference: 423961-03
EMDN: W0102060299
EMDN description: RENAL METABOLISM TESTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:04

Manufacturer products View details

VIDAS® NEPHROCHECK®

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026617387
Basic UDI-DI: 357302BUDI000859UK
Reference: 421172-03
EMDN: W0102060299
EMDN description: RENAL METABOLISM TESTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:04

Manufacturer products View details

VIDAS® NEPHROCLEAR™ CCL14

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026623401
Basic UDI-DI: 357302BUDI000908U7
Reference: 423961
EMDN: W0102060299
EMDN description: RENAL METABOLISM TESTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:59

Manufacturer products View details

VIDAS® NEPHROCHECK®

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026554903
Basic UDI-DI: 357302BUDI000859UK
Reference: 421172
EMDN: W0102060299
EMDN description: RENAL METABOLISM TESTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:57

Manufacturer products View details

Urinary Microalbumin (MAU) Diagnostic Kit(Immunochromatographic Assay)

25 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762223
Basic UDI-DI: B-06971348762223
Reference: MF-38-25
EMDN: W0102060299
EMDN description: RENAL METABOLISM TESTS - OTHER
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.07.2026 06:53

Manufacturer products Authorised representative products Authorised representative actors View details

Urinary Microalbumin (MAU) Diagnostic Kit(Immunochromatographic Assay)

20 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348760724
Basic UDI-DI: B-06971348760724
Reference: MF-38-20
EMDN: W0102060299
EMDN description: RENAL METABOLISM TESTS - OTHER
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.07.2026 06:53

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase Isoenzyme (CK-MB) Diagnostic Kit

25 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762391
Basic UDI-DI: B-06971348762391
Reference: MF-32-25
EMDN: W0102060299
EMDN description: RENAL METABOLISM TESTS - OTHER
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 23:53

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase Isoenzyme (CK-MB) Diagnostic Kit

20 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348760366
Basic UDI-DI: B-06971348760366
Reference: MF-32-20
EMDN: W0102060299
EMDN description: RENAL METABOLISM TESTS - OTHER
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 23:52

Manufacturer products Authorised representative products Authorised representative actors View details

ACTH Adrenocorticotropic Hormone (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-ACTH706-AERL
Basic UDI-DI: B-ACTH706-AERL
Reference: ACTH706-AE10Y, ACTH706-AE10N, ACTH706-AE20Y, ACTH706-AE20N
EMDN: W0102060299
EMDN description: RENAL METABOLISM TESTS - OTHER
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

Adrendcorticotrophic Hormone(ACTH)Detection Kit(CLIA)

50 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674893128
Basic UDI-DI: B-06974674893128
Reference: 18-02-0184
EMDN: W0102060299
EMDN description: RENAL METABOLISM TESTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:18

Manufacturer products Authorised representative products Authorised representative actors View details

06971763220414

mAlb Test Kit (Dry Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Lansion Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001086
UDI-DI: 06971763220414
Basic UDI-DI: B-06971763220414
Reference: 0041-03
EMDN: W0102060299
EMDN description: RENAL METABOLISM TESTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 13:47

Manufacturer products Authorised representative products Authorised representative actors View details

06970664751997

Kidney Injury Molecule 1 Rapid Test Kit (FIA)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagent

Manufacturer: BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC
Manufacturer SRN: CN-MF-000019125
UDI-DI: 06970664751997
Basic UDI-DI: B-06970664751997
Reference: 25Tests/Kit
EMDN: W0102060299
EMDN description: RENAL METABOLISM TESTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 07:33

Manufacturer products Authorised representative products Authorised representative actors View details

Microalbuminuria Determination Kit（Fluorescence Immunochromatographic Assay）

25 tests/box

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293580460
Basic UDI-DI: 697518250P110035G
Reference: P11003
EMDN: W0102060299
EMDN description: RENAL METABOLISM TESTS - OTHER
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 26.06.2026 19:22

Manufacturer products Authorised representative products Authorised representative actors View details