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02.08.2026 12:03

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280 device results listed.

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08693285187416

Calprotectin Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285187416
Basic UDI-DI: B-08693285187416
Reference: TICPT01
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:32

Manufacturer products View details

RapidFor™ HbA1c (FIA)

VMPO06

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595036648
Basic UDI-DI: B-08684595036648
Reference: VMPO06FC
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:16

Manufacturer products 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

RapidFor™ HbA1c (FIA)

VMPO06EP

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548250162
Basic UDI-DI: B-08683548250162
Reference: VMPO06
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:09

Manufacturer products View details

Harley Street Health HbA1c Professional Test

15 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Wuhan Life Origin Biotech Joint Stock Co., Ltd.
Manufacturer SRN: CN-MF-000027340
UDI-DI: 08445982000815
Basic UDI-DI: B-08445982000815
Reference: 15 Tests/Kit
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 08.07.2026 01:05

Manufacturer products Authorised representative products Authorised representative actors View details

Welleo HbA1c Professional Test

15 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Wuhan Life Origin Biotech Joint Stock Co., Ltd.
Manufacturer SRN: CN-MF-000027340
UDI-DI: 08445982000808
Basic UDI-DI: B-08445982000808
Reference: 15 Tests/Kit
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 08.07.2026 01:05

Manufacturer products Authorised representative products Authorised representative actors View details

Qassay HbA1c Professional Test

10 Tests/Kit, 15 Tests/Kit, 20 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Wuhan Life Origin Biotech Joint Stock Co., Ltd.
Manufacturer SRN: CN-MF-000027340
UDI-DI: 08445982000792
Basic UDI-DI: B-08445982000792
Reference: 15 Tests/Kit
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 08.07.2026 01:05

Manufacturer products Authorised representative products Authorised representative actors 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

Pepfast

PEPF1

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: RD Biomed (Changsha) Limited
Manufacturer SRN: CN-MF-000050308
UDI-DI: 06979259840009
Basic UDI-DI: B-06979259840009
Reference: 009-0003-00
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 07.07.2026 01:59

Manufacturer products Authorised representative products Authorised representative actors View details

Pepfast

PEPF50

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: RD Biomed (Changsha) Limited
Manufacturer SRN: CN-MF-000050308
UDI-DI: 06979259840023
Basic UDI-DI: B-06979259840023
Reference: 009-0005-00
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 07.07.2026 01:59

Manufacturer products Authorised representative products Authorised representative actors View details

Pepfast

PEPF10

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: RD Biomed (Changsha) Limited
Manufacturer SRN: CN-MF-000050308
UDI-DI: 06979259840016
Basic UDI-DI: B-06979259840016
Reference: 009-0004-00
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 07.07.2026 01:59

Manufacturer products Authorised representative products Authorised representative actors View details

Glycated Hemoglobin A1c(Boronate Acid Affinity Chromatography Method)

30T

IVD generalIVDDOn the marketKitReagent

Manufacturer: Jiangxi Medicalsystem Biological Technology Co., Ltd.
Manufacturer SRN: CN-MF-000050651
UDI-DI: 06978945081009
Basic UDI-DI: B-06978945081009
Reference: DA2204B
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Austria
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:56

Manufacturer products Authorised representative products Authorised representative actors View details

Glycated Hemoglobin A1c(Boronate Acid Affinity Chromatography Method)

20T

IVD generalIVDDOn the marketKitReagent

Manufacturer: Jiangxi Medicalsystem Biological Technology Co., Ltd.
Manufacturer SRN: CN-MF-000050651
UDI-DI: 06978945080996
Basic UDI-DI: B-06978945080996
Reference: DC2204A
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Austria
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:56

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