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343 device results listed.

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Fortel® Kidney Disease (Microalbumin) Screening Test

1400-1

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitNear-patient testingSelf testingSingle use

Manufacturer: Biomerica, Inc.
Manufacturer SRN: US-MF-000015772
UDI-DI: 00083059140019
Basic UDI-DI: B-00083059140019
Reference: 1400-1
EMDN: W0102160101
EMDN description: ALBUMIN INCL. UALBUMIN RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 04.07.2026 09:06

Manufacturer products Authorised representative products Authorised representative actors View details

Sinocare

PCH-50

IVD Class AIVDR 2017/746Not intended for EU marketInstrumentNear-patient testingProfessional testing

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175006137
Basic UDI-DI: 6934175004A0001P8
Reference: 10500022
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Austria
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 09:57

Manufacturer products Authorised representative products Authorised representative actors View details

Glycated Hemoglobin A1c Control

1×1mL

IVD generalIVDDOn the marketKitReagent

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06970291983440
Basic UDI-DI: B-06970291983440
Reference: ZK411CY
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 00:46

Manufacturer products Authorised representative products Authorised representative actors View details

Glycated Hemoglobin A1c Control

1×1mL

IVD generalIVDDOn the marketKitReagent

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06970291983433
Basic UDI-DI: B-06970291983433
Reference: ZK411BY
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 00:45

Manufacturer products Authorised representative products Authorised representative actors View details

Glycosylated Hemoglobin (HbA1c) Test Kit (Immunofluorescence)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334821984
Basic UDI-DI: B-06950334821984
Reference: 52026278
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 28.06.2026 07:44

Manufacturer products Authorised representative products Authorised representative actors View details

06950334804543

25T/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334804543
Basic UDI-DI: B-06950334804543
Reference: 52026008
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Bulgaria
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:40

Manufacturer products Authorised representative products Authorised representative actors View details

Calprotectin Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06942598226568
Basic UDI-DI: B-06942598226568
Reference: OCAL-607
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Ireland
Authorised representative: VidaQuick Biotech S.L.
Last updated: 27.06.2026 01:21

Manufacturer products Authorised representative products Authorised representative actors View details

Micro-Albumin Semi-Quantitative Rapid Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339210197
Basic UDI-DI: B-06937339210197
Reference: VNMBS-102
EMDN: W0102160101
EMDN description: ALBUMIN INCL. UALBUMIN RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 22:58

Manufacturer products Authorised representative products Authorised representative actors View details

Microalbumin Rapid Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339210180
Basic UDI-DI: B-06937339210180
Reference: VNMB-102
EMDN: W0102160101
EMDN description: ALBUMIN INCL. UALBUMIN RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 22:58

Manufacturer products Authorised representative products Authorised representative actors View details

Nuclear Matrix Protein 22 Rapid Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339209900
Basic UDI-DI: B-06937339209900
Reference: VTNMP-102
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 22:57

Manufacturer products Authorised representative products Authorised representative actors View details

Glycated Hemoglobin A1c Kit (Enzymatic Method)

IVD generalNot specifiedOn the market

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595752120
Basic UDI-DI: B-06936595752120
Reference: MJ420Y
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 18:58

Manufacturer products Authorised representative products Authorised representative actors View details

Glycated Hemoglobin A1c Kit (Latex-Enhanced Immunoturbidimetric Method)

IVD generalNot specifiedOn the market

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595750294
Basic UDI-DI: B-06936595750294
Reference: MJ411Y
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 18:54

Manufacturer products Authorised representative products Authorised representative actors View details

Glycated Hemoglobin A1c Control

IVD generalNot specifiedOn the market

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595705980
Basic UDI-DI: B-06936595705980
Reference: ZK420Y1
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 18:52

Manufacturer products Authorised representative products Authorised representative actors View details

One Step α-Fetoprotein (AFP) Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: InTec PRODUCTS, INC.
Manufacturer SRN: CN-MF-000023625
UDI-DI: 06936155803477
Basic UDI-DI: B-06936155803477
Reference: ITP12002-TC40
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Greece
Authorised representative: QbD RepS BV
Last updated: 24.06.2026 15:12

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: 06936020141116
Basic UDI-DI: B-06936020141116
Reference: IVD104-02-20t
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 24.06.2026 15:11

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: 06936020141109
Basic UDI-DI: B-06936020141109
Reference: IVD104-02-10t
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 24.06.2026 15:11

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: 06936020141093
Basic UDI-DI: B-06936020141093
Reference: IVD104-02-05t
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 24.06.2026 15:11

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: 06936020141086
Basic UDI-DI: B-06936020141086
Reference: IVD104-02-01t
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 24.06.2026 15:10

Manufacturer products Authorised representative products Authorised representative actors View details

Sinocare

IVD generalNot specifiedNo longer on the market

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175002481
Basic UDI-DI: B-06934175002481
Reference: 12600137
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 11:23

Manufacturer products Authorised representative products Authorised representative actors View details

Sinocare

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175001385
Basic UDI-DI: B-06934175001385
Reference: 12600153
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 11:23

Manufacturer products Authorised representative products Authorised representative actors View details