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458 device results listed.

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High Sensitive Cardiac Troponin-I (hs-cTnI)Test Kit (CLIA)

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-CI-hsCTI(AT)7U
Basic UDI-DI: B-CI-hsCTI(AT)7U
Reference: CI-hsCTI
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 21.09.2026 17:12

Manufacturer products Authorised representative products Authorised representative actors View details

Lp-PLA2 Test Kit (CLIA)

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-CI-LPA2(AT)KQ
Basic UDI-DI: B-CI-LPA2(AT)KQ
Reference: CI-LPA2
EMDN: W0102160799
EMDN description: CARDIAC MARKERS - RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 21.09.2026 17:12

Manufacturer products Authorised representative products Authorised representative actors View details

D-dimer Rapid Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-CDM-R402Q(AT)J8
Basic UDI-DI: B-CDM-R402Q(AT)J8
Reference: CDM-R402Q
EMDN: W0102160799
EMDN description: CARDIAC MARKERS - RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 21.09.2026 17:11

Manufacturer products Authorised representative products Authorised representative actors View details

D-dimer Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-CDM-401(AT)WD
Basic UDI-DI: B-CDM-401(AT)WD
Reference: CDM-401
EMDN: W0102160799
EMDN description: CARDIAC MARKERS - RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 21.09.2026 17:11

Manufacturer products Authorised representative products Authorised representative actors View details

CK-MB Rapid Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-CCK-R402(AT)87
Basic UDI-DI: B-CCK-R402(AT)87
Reference: CCK-R402
EMDN: W0102160701
EMDN description: CREATINE KINASE - MB MASS - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 21.09.2026 17:11

Manufacturer products Authorised representative products Authorised representative actors View details

NT-proBNP Rapid Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-CBN-R402(AT)9X
Basic UDI-DI: B-CBN-R402(AT)9X
Reference: CBN-R402
EMDN: W0102160704
EMDN description: BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 21.09.2026 17:11

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin I Rapid Test Cassette (serum/plasma/whole blood)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Spectrum for Diagnostic Industries (Joint Stock Company)
Manufacturer SRN: EG-MF-000033954
UDI-DI: G458516300309K
Basic UDI-DI: B-G458516300309K
Reference: 516 30 030
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 15.08.2026 14:01

Manufacturer products Authorised representative products Authorised representative actors View details

Fibrin Degradation Products (FDP) Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-acrFDP402FZR
Basic UDI-DI: B-acrFDP402FZR
Reference: acrFDP402F
EMDN: W0102160799
EMDN description: CARDIAC MARKERS - 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

High-Sensitivity Cardiac Troponin I

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ACO-SCTI-4023W
Basic UDI-DI: B-ACO-SCTI-4023W
Reference: ACO-SCTI-402
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:07

Manufacturer products Authorised representative products Authorised representative actors View details

ST2 Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ACO-ST2-402Q3
Basic UDI-DI: B-ACO-ST2-402Q3
Reference: ACO-ST2-402
EMDN: W0102160799
EMDN description: CARDIAC MARKERS - RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:07

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin T Rapid Test Cassette

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-CTNT-R402SQGY
Basic UDI-DI: B-CTNT-R402SQGY
Reference: CTNT-R402SQ
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 11.08.2026 23:29

Manufacturer products Authorised representative products Authorised representative actors View details

D-dimer Rapid Test Cassette

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-CDM-R402QX5
Basic UDI-DI: B-CDM-R402QX5
Reference: CDM-R402Q
EMDN: W0102160799
EMDN description: CARDIAC MARKERS - RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 11.08.2026 23:29

Manufacturer products Authorised representative products Authorised representative actors View details

CK-MB Rapid Test Cassette

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-CCK-R40279
Basic UDI-DI: B-CCK-R40279
Reference: CCK-R402
EMDN: W0102160701
EMDN description: CREATINE KINASE - MB MASS - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 11.08.2026 23:29

Manufacturer products Authorised representative products Authorised representative actors View details

NT-proBNP Rapid Test Cassette

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-CBN-R4027X
Basic UDI-DI: B-CBN-R4027X
Reference: CBN-R402
EMDN: W0102160704
EMDN description: BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 11.08.2026 23:29

Manufacturer products Authorised representative products Authorised representative actors View details

NT-proBNP FIA

CfNT4002

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-CfNT40094
Basic UDI-DI: B-CfNT40094
Reference: CfNT4002
EMDN: W0102160799
EMDN description: CARDIAC MARKERS - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 08.08.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

cTnI/Myoglobin/CK-MB FIA

CfMCT4312

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-CfMCT431XV
Basic UDI-DI: B-CfMCT431XV
Reference: CfMCT4312
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin I Rapid Test Cassette (WB/S/P)

CTNI4002

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-CTNI400ZB
Basic UDI-DI: B-CTNI400ZB
Reference: CTNI4002
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

Myoglobin/CK-MB/Troponin I Rapid Test Cassette (WB/S/P)

CMCT4312

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-CMCT431VF
Basic UDI-DI: B-CMCT431VF
Reference: CMCT4312
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

D-dimer Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-CDM-ACO401PN
Basic UDI-DI: B-CDM-ACO401PN
Reference: CDM-ACO401
EMDN: W0102160799
EMDN description: CARDIAC MARKERS - RT & POC - OTHER
First on market country: Denmark
Authorised representative: VidaQuick Biotech S.L.
Last updated: 07.08.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

CK-MB Rapid Test

CCK4001 CCK4002

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-CCK4006L
Basic UDI-DI: B-CCK4006L
Reference: CCK4001, CCK4002
EMDN: W0102160701
EMDN description: CREATINE KINASE - MB MASS - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details