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67 device results listed.

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Cholylglycine CLIA Microparticles

refer to IFU

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06970150908126
Basic UDI-DI: B-06970150908126
Reference: CMM0502
EMDN: W0102120199
EMDN description: LIVER FUNCTION - OTHER
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 18:58

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Cholyglycine (Latex Immunoturbidimetric）

Cholyglycine (Latex Immunoturbidimetric）

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145545949
Basic UDI-DI: 69471455603WB
Reference: 130502023S
EMDN: W0102120199
EMDN description: LIVER FUNCTION - OTHER
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX C IV CMIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-CIV-01100CXG
Basic UDI-DI: B-KR-CIV-01100CXG
Reference: KR-CIV-01100C
EMDN: W0102120199
EMDN description: LIVER FUNCTION - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:42

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-Col Ⅳ

IVD Class BNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912723813
Basic UDI-DI: 692591270088HR
Reference: C86047-S
EMDN: W0102120199
EMDN description: LIVER FUNCTION - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 13:38

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-Laminin

IVD Class BNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912723820
Basic UDI-DI: 692591270089HT
Reference: C86048-S
EMDN: W0102120199
EMDN description: LIVER FUNCTION - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 13:38

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Cholyglycine (Latex Immunoturbidimetric）

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145546236
Basic UDI-DI: 69471455603WB
Reference: 130502023A
EMDN: W0102120199
EMDN description: LIVER FUNCTION - OTHER
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 10.07.2026 06:44

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Cholyglycine Calibrators

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145546267
Basic UDI-DI: 69471455603WB
Reference: 160202603C
EMDN: W0102120199
EMDN description: LIVER FUNCTION - OTHER
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 10.07.2026 06:44

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Cholyglycine Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145546274
Basic UDI-DI: 69471455603WB
Reference: 160202603Q
EMDN: W0102120199
EMDN description: LIVER FUNCTION - OTHER
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 10.07.2026 06:44

Manufacturer products Authorised representative products Authorised representative actors View details

RapidFor™ Cholylglycine Rapid Test Kit (FIA)

VMPO17

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548250285
Basic UDI-DI: B-08683548250285
Reference: VMPO17
EMDN: W0102120199
EMDN description: LIVER FUNCTION - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:09

Manufacturer products View details

Collagen Type IV (CIV) eCLIA

2×100T

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984063669
Basic UDI-DI: B-06975984063669
Reference: 692014
EMDN: W0102120199
EMDN description: LIVER FUNCTION - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.07.2026 00:19

Manufacturer products Authorised representative products Authorised representative actors View details

Cholylglycine (CG) eCLIA

2×100T

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984063652
Basic UDI-DI: B-06975984063652
Reference: 692016
EMDN: W0102120199
EMDN description: LIVER FUNCTION - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.07.2026 00:19

Manufacturer products Authorised representative products Authorised representative actors View details

Collage TypeⅣ (C IV) Assay Kit (Chemiluminescent Immunoassay)

100 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Wuhan Life Origin Biotech Joint Stock Co., Ltd.
Manufacturer SRN: CN-MF-000027340
UDI-DI: 06974986814910
Basic UDI-DI: B-06974986814910
Reference: 100 Tests/Kit
EMDN: W0102120199
EMDN description: LIVER FUNCTION - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

Collage TypeⅣ (C IV) Assay Kit (Chemiluminescent Immunoassay)

50 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Wuhan Life Origin Biotech Joint Stock Co., Ltd.
Manufacturer SRN: CN-MF-000027340
UDI-DI: 06974986814903
Basic UDI-DI: B-06974986814903
Reference: 50 Tests/Kit
EMDN: W0102120199
EMDN description: LIVER FUNCTION - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

Collage TypeⅣ (C IV) Assay Kit (Chemiluminescent Immunoassay)

25 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Wuhan Life Origin Biotech Joint Stock Co., Ltd.
Manufacturer SRN: CN-MF-000027340
UDI-DI: 06974986814897
Basic UDI-DI: B-06974986814897
Reference: 25 Tests/Kit
EMDN: W0102120199
EMDN description: LIVER FUNCTION - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

Collagen IV（CIV）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）

200 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Diagnostic Technology (Shandong) Co., Ltd.
Manufacturer SRN: CN-MF-000025964
UDI-DI: 06974969982278
Basic UDI-DI: B-06974969982278
Reference: 200 Tests/kit（DR1073-3）
EMDN: W0102120199
EMDN description: LIVER FUNCTION - OTHER
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 21:13

Manufacturer products Authorised representative products Authorised representative actors View details

Collagen IV（CIV）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）

100 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Diagnostic Technology (Shandong) Co., Ltd.
Manufacturer SRN: CN-MF-000025964
UDI-DI: 06974969981707
Basic UDI-DI: B-06974969981707
Reference: 100 Tests/kit（DR1073-2）
EMDN: W0102120199
EMDN description: LIVER FUNCTION - OTHER
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 21:11

Manufacturer products Authorised representative products Authorised representative actors View details

Collagen IV（CIV）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）

50 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Diagnostic Technology (Shandong) Co., Ltd.
Manufacturer SRN: CN-MF-000025964
UDI-DI: 06974969981134
Basic UDI-DI: B-06974969981134
Reference: 50 Tests/kit（DR1073-1）
EMDN: W0102120199
EMDN description: LIVER FUNCTION - OTHER
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 21:10

Manufacturer products Authorised representative products Authorised representative actors View details

06974760129681

R1: 2×60 mL, R2: 2×20 mL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen AmTech Bioengineering Ltd., Inc.
Manufacturer SRN: CN-MF-000043067
UDI-DI: 06974760129681
Basic UDI-DI: B-06974760129681
Reference: R1: 2×60 mL, R2: 2×20 mL
EMDN: W0102120199
EMDN description: LIVER FUNCTION - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 20:40

Manufacturer products Authorised representative products Authorised representative actors View details

Collagen Type IV Assay kit(Chemiluminescence Immunoassay Method）

25 tests，50 tests，2×50 tests，100 tests，2×100 tests

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465235609
Basic UDI-DI: 697846523ProteinB09RQ
Reference: 25 tests
EMDN: W0102120199
EMDN description: LIVER FUNCTION - OTHER
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 02.07.2026 23:35

Manufacturer products Authorised representative products Authorised representative actors View details

Collagen Type IV (CLIA)

105-010718-00、105-010745-00、105-010707-00、105-010734-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415900564
Basic UDI-DI: 69449040004S-C4********6S
Reference: 105-010718-00
EMDN: W0102120199
EMDN description: LIVER FUNCTION - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:41

Manufacturer products Authorised representative products Authorised representative actors View details