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D-A074DC

INDICAID® HCY Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A074DC
Basic UDI-DI: B-A074DC
Reference: INDICAID® HCY Rapid Test
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:43

Manufacturer products Authorised representative products Authorised representative actors View details

Quantia Myoglobin

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: D-6L32-439E
Basic UDI-DI: B-6L32-439E
Reference: 6L32-43
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Spain
Authorised representative: -
Last updated: 17.07.2026 04:28

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Troponin I Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840308754
Basic UDI-DI: B-69743840308754
Reference: 3050301
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:11

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-95AX

High sensitive C-Reactive Protein (hs-CRP) Assay Kit (Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-95AX
Basic UDI-DI: B-6-95AX
Reference: "REF: USIA00000073M, USIA00000074M"
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:14

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D-6-89B4

High-sensitive Cardiac Troponin T (hs-cTnT) Assay Kit (Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-89B4
Basic UDI-DI: B-6-89B4
Reference: "REF: USIA00000081M, USIA00000082M"
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:14

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D-6-88B2

N-Terminal pro-Brain Natriuretic Peptide (NT-proBNP) Assay Kit (Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-88B2
Basic UDI-DI: B-6-88B2
Reference: "REF: USIA00000083M, USIA00000084M"
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:14

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D-6-87AY

Cardiac Troponin I (cTnI) Assay Kit (Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-87AY
Basic UDI-DI: B-6-87AY
Reference: "REF: USIA00000079M, USIA00000080M"
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:14

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D-6-86AW

Myoglobin (MYO) Assay Kit (Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-86AW
Basic UDI-DI: B-6-86AW
Reference: "REF: USIA00000077M, USIA00000078M"
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:14

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-85AU

Brain Natriuretic Peptide (BNP) Assay Kit (Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-85AU
Basic UDI-DI: B-6-85AU
Reference: "REF: USIA00000085M, USIA00000086M"
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:14

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-50A9

Myoglobin (MYO) Assay Kit (Latex Immunoturbidimetric Method)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-50A9
Basic UDI-DI: B-6-50A9
Reference: "REF: USCA00000700, USCA00000701, USCA00000702, USCA00000703, USCA00000704, U86581045M"
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:13

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-16T

Homocysteine（HCY）Reagent Kit (Enzymatic Cycling Method)

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-16T
Basic UDI-DI: B-6-16T
Reference: "REF: U83582015M, U83582030M, U83589045M, U83585015M, U83511020M, U83520030M"
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:09

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-133FF

Cardiac troponin I (cTnI ) Test Kit (Latex Immunoturbidimetric Method)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-133FF
Basic UDI-DI: B-6-133FF
Reference: "REF: USCA00000740, USCA00000743 USCA00000741, USCA00000742 USCA00000744, USCA00000781"
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:08

Manufacturer products Authorised representative products Authorised representative actors View details

06954418517374

25 Tests /kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shanghai Medconn Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000038615
UDI-DI: 06954418517374
Basic UDI-DI: B-06954418517374
Reference: NA
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Spain
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 16.07.2026 18:57

Manufacturer products Authorised representative products Authorised representative actors View details

hs-cTnI Reagent kit

50 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shanghai Medconn Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000038615
UDI-DI: 06954418517381
Basic UDI-DI: B-06954418517381
Reference: /
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Spain
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 16.07.2026 18:57

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS BNP

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133043400
Basic UDI-DI: 880613300572CM
Reference: SMFP-83
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Netherlands
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS hsCRP

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133043226
Basic UDI-DI: 880613300617CJ
Reference: SMFP-78
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Austria
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS NT-proBNP/ST2

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133042830
Basic UDI-DI: 880613300626CK
Reference: SMFP-85
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ NT-proBNP/ST2

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133042793
Basic UDI-DI: 880613300029BT
Reference: CFPC-163
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS CK-MB Neo

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133042380
Basic UDI-DI: 880613300608CH
Reference: SMFP-128
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

hs-cTnI STAT (eCLIA)

50T, 2×50T, 100T, 2×100T

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06978139071724
Basic UDI-DI: 69703416803205080JK
Reference: 0320513401
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 11:03

Manufacturer products Authorised representative products Authorised representative actors View details