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343 device results listed.

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PGⅠ/PG Ⅱ/H. pylori antibody/Gastrin 17 Combo Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-TGT-R445Q(AT)MP
Basic UDI-DI: B-TGT-R445Q(AT)MP
Reference: TGT-R445Q
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 21.09.2026 17:34

Manufacturer products Authorised representative products Authorised representative actors View details

PGⅠ/PG Ⅱ/H. pylori antibody Combo Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-TGT-R435Q(AT)M6
Basic UDI-DI: B-TGT-R435Q(AT)M6
Reference: TGT-R435Q
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 21.09.2026 17:34

Manufacturer products Authorised representative products Authorised representative actors View details

TPOAb Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-FI-TPOB-402(AT)MW
Basic UDI-DI: B-FI-TPOB-402(AT)MW
Reference: FI-TPOB-402
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 21.09.2026 17:26

Manufacturer products Authorised representative products Authorised representative actors View details

TGAb Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-FI-TGB-402(AT)K2
Basic UDI-DI: B-FI-TGB-402(AT)K2
Reference: FI-TGB-402
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 21.09.2026 17:26

Manufacturer products Authorised representative products Authorised representative actors View details

MxA/CRP Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-FI-MXCR-402(AT)N7
Basic UDI-DI: B-FI-MXCR-402(AT)N7
Reference: FI-MXCR-402
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 21.09.2026 17:25

Manufacturer products Authorised representative products Authorised representative actors View details

ROM Plus ES Complete Kit

ROM-1025

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesNear-patient testingProfessional testingReagentSingle useSterile

Manufacturer: Clinical Innovations, LLC
Manufacturer SRN: US-MF-000031386
UDI-DI: 00814247020406
Basic UDI-DI: B-00814247020406
Reference: ROM-1025
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: France
Authorised representative: MVF
Last updated: 13.08.2026 10:24

Manufacturer products Authorised representative products Authorised representative actors View details

MxA+CRP Combo Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-acrMC402RQ
Basic UDI-DI: B-acrMC402RQ
Reference: acrMC402
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.08.2026 06:54

Manufacturer products Authorised representative products Authorised representative actors View details

Inhalant-Food Allergen-specific IgE Antibodies Rapid Test Kit

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-acrIFIgE4214W2Y
Basic UDI-DI: B-acrIFIgE4214W2Y
Reference: acrIFIgE4214W
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.08.2026 06:54

Manufacturer products Authorised representative products Authorised representative actors View details

Antinuclear Antibody (ANA) Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-acrANA402R9
Basic UDI-DI: B-acrANA402R9
Reference: acrANA402
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.08.2026 06:53

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-TPO Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-acrTPO402FDT
Basic UDI-DI: B-acrTPO402FDT
Reference: acrTPO402F
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:14

Manufacturer products Authorised representative products Authorised representative actors View details

PCT Semi-quantitative Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-acrPCTU402ED
Basic UDI-DI: B-acrPCTU402ED
Reference: acrPCTU402
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:14

Manufacturer products Authorised representative products Authorised representative actors View details

PGⅠ/PG Ⅱ/H. pylori antibody/Gastrin 17 Combo Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-TGT-ACOR445QUJ
Basic UDI-DI: B-TGT-ACOR445QUJ
Reference: TGT-ACOR445Q
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:13

Manufacturer products Authorised representative products Authorised representative actors View details

PGⅠ/PG Ⅱ/H. pylori antibody Combo Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-TGT-ACOR435QUD
Basic UDI-DI: B-TGT-ACOR435QUD
Reference: TGT-ACOR435Q
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:13

Manufacturer products Authorised representative products Authorised representative actors View details

MxA/CRP Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ACO-MXCR-4027P
Basic UDI-DI: B-ACO-MXCR-4027P
Reference: ACO-MXCR-402
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:06

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-CCP Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ACO-CCP-402JM
Basic UDI-DI: B-ACO-CCP-402JM
Reference: ACO-CCP-402
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:06

Manufacturer products Authorised representative products Authorised representative actors View details

FinecareTM

W207-C7PM

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289801249
Basic UDI-DI: 69332898CE0124EK
Reference: W207-C7PM
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Germany
Safety summary (SSCP/SSP): CSD-W207(2)-06 · Rev. 01
Authorised representative: QbD RepS BV
Last updated: 09.08.2026 23:23

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Calprotectin Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983188760
Basic UDI-DI: B-06936983188760
Reference: OCAL-R602Q
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Ireland
Authorised representative: VidaQuick Biotech S.L.
Last updated: 05.08.2026 14:29

Manufacturer products Authorised representative products Authorised representative actors View details

IgA Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ACO-IGA-402JA
Basic UDI-DI: B-ACO-IGA-402JA
Reference: ACO-IGA-402
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Cyprus
Authorised representative: VidaQuick Biotech S.L.
Last updated: 04.08.2026 19:29

Manufacturer products Authorised representative products Authorised representative actors View details

06941571855016

R55-112

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571855016
Basic UDI-DI: B-06941571855016
Reference: R55-112
EMDN: W0102160101
EMDN description: ALBUMIN INCL. UALBUMIN RT & POC
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:55

Manufacturer products Authorised representative products Authorised representative actors View details

06941571855009

R55-110

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571855009
Basic UDI-DI: B-06941571855009
Reference: R55-110
EMDN: W0102160101
EMDN description: ALBUMIN INCL. UALBUMIN RT & POC
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:55

Manufacturer products Authorised representative products Authorised representative actors View details