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110 device results listed.

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LIA-ANA-Profile

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: D-L89401G5V9
Basic UDI-DI: B-L89401G5V9
Reference: L89401G5
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 14.07.2026 03:48

Manufacturer products Authorised representative products Authorised representative actors View details

LIA-ANA-Profile

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: D-L89401G4-222
Basic UDI-DI: B-L89401G4-222
Reference: L89401G4-2
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 14.07.2026 03:48

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LIA-ANA-Profile

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: D-L89401G3-2ZS
Basic UDI-DI: B-L89401G3-2ZS
Reference: L89401G3-2
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 14.07.2026 03:48

Manufacturer products Authorised representative products Authorised representative actors View details

LIA-ANA-Profile

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: D-L89401G2-2ZM
Basic UDI-DI: B-L89401G2-2ZM
Reference: L89401G2-2
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 14.07.2026 03:48

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LIA-ANA-Profile

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: D-L89401G1-2ZG
Basic UDI-DI: B-L89401G1-2ZG
Reference: L89401G1-2
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 14.07.2026 03:48

Manufacturer products Authorised representative products Authorised representative actors View details

cTnI/CK-MB/Myo Quantitative Test Kit (Time-Resolved FIA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FDCAR-T402aXH
Basic UDI-DI: B-FDCAR-T402aXH
Reference: FDCAR-T402a
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

cTnI/CK-MB/Myo Quantitative Test Kit (Time-Resolved FIA)

FDCAR-T402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FDCAR-T402aHG92
Basic UDI-DI: B-FDCAR-T402aHG92
Reference: FDCAR-T402a
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

06979878281467

Cardiac Troponin I/N-terminal pro-Brain Natriuretic Peptide/D-Dimer Test (Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Huzhou Jierunxin Biotechnology Co., LTD
Manufacturer SRN: CN-MF-000047637
UDI-DI: 06979878281467
Basic UDI-DI: B-06979878281467
Reference: 1001040
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
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

06979878281450

Cardiac troponin I /Myoglobin/creatine kinase isoenzymes Test (Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Huzhou Jierunxin Biotechnology Co., LTD
Manufacturer SRN: CN-MF-000047637
UDI-DI: 06979878281450
Basic UDI-DI: B-06979878281450
Reference: 1001039
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
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

06979878281399

Cardiac Troponin I /Heart Type Fatty Acid Binding Protein Test (Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Huzhou Jierunxin Biotechnology Co., LTD
Manufacturer SRN: CN-MF-000047637
UDI-DI: 06979878281399
Basic UDI-DI: B-06979878281399
Reference: 1001033
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
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

06979878281221

C-peptide/insulinTest (Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Huzhou Jierunxin Biotechnology Co., LTD
Manufacturer SRN: CN-MF-000047637
UDI-DI: 06979878281221
Basic UDI-DI: B-06979878281221
Reference: 1001052
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Austria
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 02:50

Manufacturer products Authorised representative products Authorised representative actors View details

PCT/hs-CRP+conventional CRP Combo Test Kit (Immunofluorescence Method)

40 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
Manufacturer SRN: CN-MF-000019908
UDI-DI: 06978896418367
Basic UDI-DI: B-06978896418367
Reference: W-IF-PCT-CRP-40
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:56

Manufacturer products Authorised representative products Authorised representative actors View details

06978896416073

40 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
Manufacturer SRN: CN-MF-000019908
UDI-DI: 06978896416073
Basic UDI-DI: B-06978896416073
Reference: W-IF2-PC-40
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:50

Manufacturer products Authorised representative products Authorised representative actors View details

06978896416066

20 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
Manufacturer SRN: CN-MF-000019908
UDI-DI: 06978896416066
Basic UDI-DI: B-06978896416066
Reference: W-IF2-PC-20
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:50

Manufacturer products Authorised representative products Authorised representative actors View details

06978896416059

40 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
Manufacturer SRN: CN-MF-000019908
UDI-DI: 06978896416059
Basic UDI-DI: B-06978896416059
Reference: W-IF2-SAA-CRP-40
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:50

Manufacturer products Authorised representative products Authorised representative actors View details

06978896416042

20 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
Manufacturer SRN: CN-MF-000019908
UDI-DI: 06978896416042
Basic UDI-DI: B-06978896416042
Reference: W-IF2-SAA-CRP-20
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:50

Manufacturer products Authorised representative products Authorised representative actors View details

06978896416035

40 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
Manufacturer SRN: CN-MF-000019908
UDI-DI: 06978896416035
Basic UDI-DI: B-06978896416035
Reference: W-IF2-PGⅠ-PGⅡ-40
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:50

Manufacturer products Authorised representative products Authorised representative actors View details

06978896415618

40 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
Manufacturer SRN: CN-MF-000019908
UDI-DI: 06978896415618
Basic UDI-DI: B-06978896415618
Reference: W-IF2-Cardio3-40
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:48

Manufacturer products Authorised representative products Authorised representative actors View details

06978896415601

20 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
Manufacturer SRN: CN-MF-000019908
UDI-DI: 06978896415601
Basic UDI-DI: B-06978896415601
Reference: W-IF2-Cardio3-20
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:48

Manufacturer products Authorised representative products Authorised representative actors View details

06977181060038

100tests / box,

IVD generalIVDDOn the marketKitReagentSingle use

Manufacturer: PoonBio(Nanjing) Co., Ltd
Manufacturer SRN: CN-MF-000045245
UDI-DI: 06977181060038
Basic UDI-DI: B-06977181060038
Reference: 100tests / box,
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 07.07.2026 01:11

Manufacturer products Authorised representative products Authorised representative actors View details