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55 device results listed.

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D-EIM4101301DZ

Urinary Microalbumin (mAlb) Assay Kit by Fluorescence Immunochromatographic Method

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4101301DZ
Basic UDI-DI: B-EIM4101301DZ
Reference: EIM4101301
EMDN: W0102160101
EMDN description: ALBUMIN INCL. UALBUMIN RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:47

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNM0000180725001MR

Strip, Cassette, Midstream and Urine Cup

IVD self-testing devicesIVDDOn the marketAnimal tissuesHuman tissuesKitSelf testingSingle use

Manufacturer: Shanghai Chemtron Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000018072
UDI-DI: D-CNM0000180725001MR
Basic UDI-DI: B-CNM0000180725001MR
Reference: 5001C 5001S 5001D 5001B
EMDN: W0102160101
EMDN description: ALBUMIN INCL. UALBUMIN RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

Accu-Tell® Micro-Albumin Semi-quantitative Strip (Urine)

Strip

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: D-ABT-MAU-A305W3
Basic UDI-DI: B-ABT-MAU-A305W3
Reference: ABT-MAU-A305
EMDN: W0102160101
EMDN description: ALBUMIN INCL. UALBUMIN RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 12.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

D-811049PF

MAU Rapid Detect

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024153
UDI-DI: D-811049PF
Basic UDI-DI: B-811049PF
Reference: 811049
EMDN: W0102160101
EMDN description: ALBUMIN INCL. UALBUMIN RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 09:57

Manufacturer products Authorised representative products Authorised representative actors View details

Eclipse PLUS

Eclipse PLUS Microalbumin Reagent Kit

IVD generalIVDDNo longer on the marketAnimal tissuesNear-patient testingReagentSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487608BMATYU
Basic UDI-DI: B-47136487608BMATYU
Reference: S5641010 S5641011
EMDN: W0102160101
EMDN description: ALBUMIN INCL. UALBUMIN RT & POC
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

EZ-Microalbumin Screening Test

1400-25

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testing

Manufacturer: BIOEUROPE GmbH
Manufacturer SRN: DE-MF-000039230
UDI-DI: 42623675614257
Basic UDI-DI: B-42623675614257
Reference: 1400-25
EMDN: W0102160101
EMDN description: ALBUMIN INCL. UALBUMIN RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 11.07.2026 19:36

Manufacturer products View details

Fortel Kidney Disease (Microalbumin) Screening Test

1400-1

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: BIOEUROPE GmbH
Manufacturer SRN: DE-MF-000039230
UDI-DI: D-1400-1L9
Basic UDI-DI: B-1400-1L9
Reference: 1400-1
EMDN: W0102160101
EMDN description: ALBUMIN INCL. UALBUMIN RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 11.07.2026 06:08

Manufacturer products View details

AUTODXTM U-Albumin Test

Dx.UAlbumin

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DxGen Corp.
Manufacturer SRN: KR-MF-000030876
UDI-DI: 08800031900353
Basic UDI-DI: B-08800031900353
Reference: E1C800
EMDN: W0102160101
EMDN description: ALBUMIN INCL. UALBUMIN RT & POC
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 09.07.2026 22:06

Manufacturer products Authorised representative products Authorised representative actors View details

RapidFor™ Microalbumin Rapid Test Kit (FIA)

VMPO49

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548250872
Basic UDI-DI: B-08683548250872
Reference: VMPO49
EMDN: W0102160101
EMDN description: ALBUMIN INCL. UALBUMIN RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:10

Manufacturer products View details

06979878281542

Microalbumin Test (Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Huzhou Jierunxin Biotechnology Co., LTD
Manufacturer SRN: CN-MF-000047637
UDI-DI: 06979878281542
Basic UDI-DI: B-06979878281542
Reference: 1001054
EMDN: W0102160101
EMDN description: ALBUMIN INCL. UALBUMIN RT & POC
First on market country: Austria
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 02:51

Manufacturer products Authorised representative products Authorised representative actors View details

06979355921169

Urinary Microalbumin (mALB) Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000050949
UDI-DI: 06979355921169
Basic UDI-DI: B-06979355921169
Reference: 100 tests/kit
EMDN: W0102160101
EMDN description: ALBUMIN INCL. UALBUMIN RT & POC
First on market country: Spain
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 07.07.2026 02:02

Manufacturer products Authorised representative products Authorised representative actors View details

06979355921152

Urinary Microalbumin (mALB) Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000050949
UDI-DI: 06979355921152
Basic UDI-DI: B-06979355921152
Reference: 50 tests/kit
EMDN: W0102160101
EMDN description: ALBUMIN INCL. UALBUMIN RT & POC
First on market country: Spain
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 07.07.2026 02:02

Manufacturer products Authorised representative products Authorised representative actors View details

06979355921145

Urinary Microalbumin (mALB) Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000050949
UDI-DI: 06979355921145
Basic UDI-DI: B-06979355921145
Reference: 40 tests/kit
EMDN: W0102160101
EMDN description: ALBUMIN INCL. UALBUMIN RT & POC
First on market country: Spain
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 07.07.2026 02:02

Manufacturer products Authorised representative products Authorised representative actors View details

06979355921138

Urinary Microalbumin (mALB) Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000050949
UDI-DI: 06979355921138
Basic UDI-DI: B-06979355921138
Reference: 25 tests/kit
EMDN: W0102160101
EMDN description: ALBUMIN INCL. UALBUMIN RT & POC
First on market country: Spain
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 07.07.2026 02:02

Manufacturer products Authorised representative products Authorised representative actors View details

06979355921121

Urinary Microalbumin (mALB) Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000050949
UDI-DI: 06979355921121
Basic UDI-DI: B-06979355921121
Reference: 10 tests/kit
EMDN: W0102160101
EMDN description: ALBUMIN INCL. UALBUMIN RT & POC
First on market country: Spain
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 07.07.2026 02:02

Manufacturer products Authorised representative products Authorised representative actors View details

06979355921114

Urinary Microalbumin (mALB) Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000050949
UDI-DI: 06979355921114
Basic UDI-DI: B-06979355921114
Reference: 1 test/kit
EMDN: W0102160101
EMDN description: ALBUMIN INCL. UALBUMIN RT & POC
First on market country: Spain
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 07.07.2026 02:02

Manufacturer products Authorised representative products Authorised representative actors View details

Microalbumin (mAlb) Assay Kits (Lateral Flow Immunoassay)

25 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06978139075791
Basic UDI-DI: B-06978139075791
Reference: 745006
EMDN: W0102160101
EMDN description: ALBUMIN INCL. UALBUMIN RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.07.2026 01:40

Manufacturer products Authorised representative products Authorised representative actors View details

Microalbuminuria (mAlb) Test Kit (Fluorescence immunochromatography method)

50 tests / kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOBASE POCT CO.,LTD
Manufacturer SRN: CN-MF-000045945
UDI-DI: 06976374750381
Basic UDI-DI: B-06976374750381
Reference: 50 tests / kit（DR014-2）
EMDN: W0102160101
EMDN description: ALBUMIN INCL. UALBUMIN RT & POC
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 07.07.2026 00:42

Manufacturer products Authorised representative products Authorised representative actors View details

Microalbuminuria (mAlb) Test Kit (Fluorescence immunochromatography method)

25 tests / kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOBASE POCT CO.,LTD
Manufacturer SRN: CN-MF-000045945
UDI-DI: 06976374750374
Basic UDI-DI: B-06976374750374
Reference: 25 tests / kit（DR014-4）
EMDN: W0102160101
EMDN description: ALBUMIN INCL. UALBUMIN RT & POC
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 07.07.2026 00:42

Manufacturer products Authorised representative products Authorised representative actors View details

Microalbuminuria (mAlb) Test Kit (Fluorescence immunochromatography method)

20 tests / kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOBASE POCT CO.,LTD
Manufacturer SRN: CN-MF-000045945
UDI-DI: 06976374750367
Basic UDI-DI: B-06976374750367
Reference: 20 tests / kit（DR014-1）
EMDN: W0102160101
EMDN description: ALBUMIN INCL. UALBUMIN RT & POC
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 07.07.2026 00:42

Manufacturer products Authorised representative products Authorised representative actors View details