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01.08.2026 13:11

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47 device results listed.

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D-R225152H

50 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R225152H
Basic UDI-DI: B-R225152H
Reference: R22515
EMDN: W0102160705
EMDN description: HEART-TYPE FATTY ACID-BINDING PROTEIN - RT & POC
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 15:08

Manufacturer products Authorised representative products Authorised representative actors View details

D-R225142F

30 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R225142F
Basic UDI-DI: B-R225142F
Reference: R22514
EMDN: W0102160705
EMDN description: HEART-TYPE FATTY ACID-BINDING PROTEIN - RT & POC
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 15:08

Manufacturer products Authorised representative products Authorised representative actors View details

D-R225132D

200 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R225132D
Basic UDI-DI: B-R225132D
Reference: R22513
EMDN: W0102160705
EMDN description: HEART-TYPE FATTY ACID-BINDING PROTEIN - RT & POC
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 15:08

Manufacturer products Authorised representative products Authorised representative actors View details

D-R225122B

100 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R225122B
Basic UDI-DI: B-R225122B
Reference: R22512
EMDN: W0102160705
EMDN description: HEART-TYPE FATTY ACID-BINDING PROTEIN - RT & POC
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 15:08

Manufacturer products Authorised representative products Authorised representative actors View details

D-R2251129

50 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R2251129
Basic UDI-DI: B-R2251129
Reference: R22511
EMDN: W0102160705
EMDN description: HEART-TYPE FATTY ACID-BINDING PROTEIN - RT & POC
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 15:08

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S085RZ

BF S08

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-S085RZ
Basic UDI-DI: B-CNMF000014455-BF-S085RZ
Reference: BF-S085
EMDN: W0102160705
EMDN description: HEART-TYPE FATTY ACID-BINDING PROTEIN - RT & POC
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:50

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S084RX

BF S08

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-S084RX
Basic UDI-DI: B-CNMF000014455-BF-S084RX
Reference: BF-S084
EMDN: W0102160705
EMDN description: HEART-TYPE FATTY ACID-BINDING PROTEIN - RT & POC
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:49

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S083RV

BF S08

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-S083RV
Basic UDI-DI: B-CNMF000014455-BF-S083RV
Reference: BF-S083
EMDN: W0102160705
EMDN description: HEART-TYPE FATTY ACID-BINDING PROTEIN - RT & POC
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:49

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S082RT

BF S08

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-S082RT
Basic UDI-DI: B-CNMF000014455-BF-S082RT
Reference: BF-S082
EMDN: W0102160705
EMDN description: HEART-TYPE FATTY ACID-BINDING PROTEIN - RT & POC
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:49

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S081RR

BF S08

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-S081RR
Basic UDI-DI: B-CNMF000014455-BF-S081RR
Reference: BF-S081
EMDN: W0102160705
EMDN description: HEART-TYPE FATTY ACID-BINDING PROTEIN - RT & POC
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:49

Manufacturer products Authorised representative products Authorised representative actors View details

Heart Fatty Acid Binding Protein Test Kit (FIA)

VID13

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID132Q
Basic UDI-DI: B-VID132Q
Reference: VID13-03-011
EMDN: W0102160705
EMDN description: HEART-TYPE FATTY ACID-BINDING PROTEIN - RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

H-FABP Test Kit FIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-H-FABP-D06aBK
Basic UDI-DI: B-H-FABP-D06aBK
Reference: H-FABP-D06a
EMDN: W0102160705
EMDN description: HEART-TYPE FATTY ACID-BINDING PROTEIN - RT & POC
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 14.07.2026 00:44

Manufacturer products Authorised representative products Authorised representative actors View details

D-808039QJ

H-FABP Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024153
UDI-DI: D-808039QJ
Basic UDI-DI: B-808039QJ
Reference: 808039
EMDN: W0102160705
EMDN description: HEART-TYPE FATTY ACID-BINDING PROTEIN - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 09:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-808039-1B9

H-FABP quantitative rapid test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024153
UDI-DI: D-808039-1B9
Basic UDI-DI: B-808039-1B9
Reference: 808039-1
EMDN: W0102160705
EMDN description: HEART-TYPE FATTY ACID-BINDING PROTEIN - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 09:53

Manufacturer products Authorised representative products Authorised representative actors View details

TruVue

H-FABP Test (FIA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763464
Basic UDI-DI: B-15065023763464
Reference: TV20008
EMDN: W0102160705
EMDN description: HEART-TYPE FATTY ACID-BINDING PROTEIN - RT & POC
First on market country: Poland
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:35

Manufacturer products Authorised representative products Authorised representative actors View details

RapidFor™ H-FABP Rapid Test Kit (FIA)

VMPO22

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548250339
Basic UDI-DI: B-08683548250339
Reference: VMPO22
EMDN: W0102160705
EMDN description: HEART-TYPE FATTY ACID-BINDING PROTEIN - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:09

Manufacturer products View details

RapidFor™ H-FABP Rapid Test Kit

VMD53

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683347941599
Basic UDI-DI: B-08683347941599
Reference: VMD53
EMDN: W0102160705
EMDN description: HEART-TYPE FATTY ACID-BINDING PROTEIN - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:05

Manufacturer products View details

Heart-type Fatty Acid-Binding Protein (H-FABP) Test Kit (Fluorescence immunochromatography method)

50 tests / kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOBASE POCT CO.,LTD
Manufacturer SRN: CN-MF-000045945
UDI-DI: 06976374750237
Basic UDI-DI: B-06976374750237
Reference: 50 tests / kit（DR009-2）
EMDN: W0102160705
EMDN description: HEART-TYPE FATTY ACID-BINDING PROTEIN - RT & POC
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 07.07.2026 00:41

Manufacturer products Authorised representative products Authorised representative actors View details

Heart-type Fatty Acid-Binding Protein (H-FABP) Test Kit (Fluorescence immunochromatography method)

25 tests / kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOBASE POCT CO.,LTD
Manufacturer SRN: CN-MF-000045945
UDI-DI: 06976374750220
Basic UDI-DI: B-06976374750220
Reference: 25 tests / kit（DR009-4）
EMDN: W0102160705
EMDN description: HEART-TYPE FATTY ACID-BINDING PROTEIN - RT & POC
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 07.07.2026 00:41

Manufacturer products Authorised representative products Authorised representative actors View details

Heart-type Fatty Acid-Binding Protein (H-FABP) Test Kit (Fluorescence immunochromatography method)

20 tests / kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOBASE POCT CO.,LTD
Manufacturer SRN: CN-MF-000045945
UDI-DI: 06976374750213
Basic UDI-DI: B-06976374750213
Reference: 20 tests / kit（DR009-1）
EMDN: W0102160705
EMDN description: HEART-TYPE FATTY ACID-BINDING PROTEIN - RT & POC
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 07.07.2026 00:41

Manufacturer products Authorised representative products Authorised representative actors View details