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343 device results listed.

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One Step Microalbumin Test Cassette (Urine)

GIHSA-102a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GIHSA-102aHG3L
Basic UDI-DI: B-GIHSA-102aHG3L
Reference: GIHSA-102a
EMDN: W0102160101
EMDN description: ALBUMIN INCL. UALBUMIN RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Microalbumin Test Cassette (Urine)

GIHSA-102a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GIHSA-102a4A
Basic UDI-DI: B-GIHSA-102a4A
Reference: GIHSA-102a
EMDN: W0102160101
EMDN description: ALBUMIN INCL. UALBUMIN RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Microalbumin Test Strip (Urine)

GIHSA-101a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GIHSA-101aHG3D
Basic UDI-DI: B-GIHSA-101aHG3D
Reference: GIHSA-101a
EMDN: W0102160101
EMDN description: ALBUMIN INCL. UALBUMIN RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Microalbumin Test Strip (Urine)

GIHSA-101a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GIHSA-101a47
Basic UDI-DI: B-GIHSA-101a47
Reference: GIHSA-101a
EMDN: W0102160101
EMDN description: ALBUMIN INCL. UALBUMIN RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

D-FA0002YU

50T/kit

IVD generalIVDDOn the marketKit

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: D-FA0002YU
Basic UDI-DI: B-FA0002YU
Reference: 52027008
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Bulgaria
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 21:15

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4101303E5

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-EIM4101303E5
Basic UDI-DI: B-EIM4101303E5
Reference: EIM4101303
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-EIM4101302E3

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-EIM4101302E3
Basic UDI-DI: B-EIM4101302E3
Reference: EIM4101302
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-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

On Call

QGS-221

IVD generalIVDDOn the marketAnimal tissuesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: D-CNMF000006977G136-112UG
Basic UDI-DI: B-CNMF000006977G136-112UG
Reference: G136-112
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 13.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNM0000180729001NM

Strip, Cassette

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Shanghai Chemtron Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000018072
UDI-DI: D-CNM0000180729001NM
Basic UDI-DI: B-CNM0000180729001NM
Reference: 9001C 9001S
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Greece
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

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

Glycated Hemoglobin (HbA1c) Assay Kit (Latex-enhanced Immunoturbidimetric Method)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: YHLO BIOTECH (NANJING) CO., LTD.
Manufacturer SRN: CN-MF-000050474
UDI-DI: D-86H40TSCVU
Basic UDI-DI: B-86H40TSCVU
Reference: 86H40TSC
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 20:25

Manufacturer products Authorised representative products Authorised representative actors View details

Glycated Hemoglobin (HbA1c) Assay Kit (Latex-enhanced Immunoturbidimetric Method)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: YHLO BIOTECH (NANJING) CO., LTD.
Manufacturer SRN: CN-MF-000050474
UDI-DI: D-86H160TSCCM
Basic UDI-DI: B-86H160TSCCM
Reference: 86H160TSC
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 20:25

Manufacturer products Authorised representative products Authorised representative actors View details

CRP Test Kit (Serum/plasma/whole blood)

CRP0026

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Neo-nostics (Suzhou) Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000013087
UDI-DI: 86979834610559
Basic UDI-DI: B-86979834610559
Reference: CRP0026
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 17:23

Manufacturer products Authorised representative products Authorised representative actors View details

Simple Calprotectina

9.049.XXX.YY.ZZZ

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-84295779049Y7HN
Basic UDI-DI: B-84295779049Y7HN
Reference: 9.049.XXX.YY.ZZZ
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:09

Manufacturer products View details

CONTROL POSITIVO EN SECO CALPROTECTINA || DRY CALPROTECTIN POSITIVE CONTROL

9.049.XXX.12.ZZZ

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-8429577904912DP4G
Basic UDI-DI: B-8429577904912DP4G
Reference: 9.049.XXX.12.ZZZ
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:09

Manufacturer products View details

biotical Calprotectin + Lactoferrin Card (+PC +NC)

biotical Calprotectin + Lactoferrin Card (+PC +NC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo Calprotectin + Lactoferrin +1 C. Negativo universal)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: BIOTICAL HEALTH S.L.U
Manufacturer SRN: ES-MF-000018831
UDI-DI: 84365942144178
Basic UDI-DI: B-84365942144178
Reference: RTB25CLCN
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:02

Manufacturer products View details

biotical Calprotectin + Lactoferrin Card (+PC)

biotical Calprotectin + Lactoferrin Card (+PC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo Calprotectin + Lactoferrin)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: BIOTICAL HEALTH S.L.U
Manufacturer SRN: ES-MF-000018831
UDI-DI: 84365942144000
Basic UDI-DI: B-84365942144000
Reference: RTB25CLC
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:02

Manufacturer products View details

biotical Calprotectin + Lactoferrin Card

biotical Calprotectin + Lactoferrin Card / 25 test rápidos con viales para muestra fecal (sin controles externos).

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: BIOTICAL HEALTH S.L.U
Manufacturer SRN: ES-MF-000018831
UDI-DI: 84365942143942
Basic UDI-DI: B-84365942143942
Reference: RTB25CL
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:02

Manufacturer products View details