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iFlash-PIVKA-Ⅱ

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912716884
Basic UDI-DI: 692591270184HN
Reference: C86137
EMDN: W0102030199
EMDN description: CANCER ANTIGENS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:34

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-Free PSA

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912715924
Basic UDI-DI: 692591270098HU
Reference: C86001-L
EMDN: W0102030114
EMDN description: FREE PROSTATIC SPECIFIC ANTIGEN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-Total PSA

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912715917
Basic UDI-DI: 692591270097HS
Reference: C86000-L
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-CYFRA 21-1

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912715511
Basic UDI-DI: 692591270027H5
Reference: C86028-L
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:29

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-NSE

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912711766
Basic UDI-DI: 692591270028H7
Reference: C86029-L
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:29

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-CA 15-3

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912711759
Basic UDI-DI: 692591270025GZ
Reference: C86006-L
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:29

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-AFP

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912711728
Basic UDI-DI: 692591270022GT
Reference: C86003-L
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:29

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-CA 19-9

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912711629
Basic UDI-DI: 692591270026H3
Reference: C86007-L
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:29

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-CA 125

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912711612
Basic UDI-DI: 692591270024GX
Reference: C86005-L
EMDN: W0102030106
EMDN description: CANCER ANTIGEN 125
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:29

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-CEA

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912711605
Basic UDI-DI: 692591270023GV
Reference: C86004-L
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

Alpha-fetoprotein Detection Kit (Chemiluminescence Immunoassay)

1×100 Tests/kit, 1×50 Tests/kit, 2×50 Tests/kit

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

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794588562
Basic UDI-DI: 69257945W0102039001R0PV
Reference: 3013790
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

Cancer Antigen 19-9 Detection Kit (Chemiluminescence Immunoassay)

1×100 Tests/kit, 1×50 Tests/kit, 2×50 Tests/kit

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

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794588302
Basic UDI-DI: 69257945W0102030103R0LV
Reference: 3013798
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

FLEX Monoclonal Mouse Anti-Human CD10, Clone DAK-CD10, Ready-to-Use (Dako Omnis)

GA786/IR786

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Agilent Technologies Singapore (International) Pte Ltd
Manufacturer SRN: SG-MF-000014448
UDI-DI: 05700573004577
Basic UDI-DI: 570057R0301P3007C008701NK
Reference: GA786
EMDN: W0102030199
EMDN description: CANCER ANTIGENS - OTHER
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 31.07.2026 11:57

Manufacturer products Authorised representative products Authorised representative actors View details

FLEX Monoclonal Mouse Anti-Human CD246 ALK Protein, Clone OTI1A4, Ready-to-Use (Dako Omnis)

GA785

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Agilent Technologies Singapore (International) Pte Ltd
Manufacturer SRN: SG-MF-000014448
UDI-DI: 05700573004560
Basic UDI-DI: 570057R0301P3007C015701N9
Reference: GA785
EMDN: W0102030199
EMDN description: CANCER ANTIGENS - OTHER
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 31.07.2026 11:57

Manufacturer products Authorised representative products Authorised representative actors View details

FLEX Monoclonal Rabbit Anti-Human p40, Clone DAK-p40, Ready-to-Use (Dako Omnis)

GA784

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Agilent Technologies Singapore (International) Pte Ltd
Manufacturer SRN: SG-MF-000014448
UDI-DI: 05700573004553
Basic UDI-DI: 570057R0301P3007C008601NE
Reference: GA784
EMDN: W0102030116
EMDN description: SQUAMOUS CELL CARCINOMA ANTIGEN
First on market country: Germany
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 31.07.2026 11:54

Manufacturer products Authorised representative products Authorised representative actors View details

FLEX Monoclonal Mouse Anti-Human p16, Clone JC8, Ready-to-Use (Dako Omnis)

GA783

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Agilent Technologies Singapore (International) Pte Ltd
Manufacturer SRN: SG-MF-000014448
UDI-DI: 05700573004546
Basic UDI-DI: 570057R0301P3007C008501N9
Reference: GA783
EMDN: W0102030124
EMDN description: CANCER ANTIGEN P16
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 31.07.2026 11:54

Manufacturer products Authorised representative products Authorised representative actors View details

FLEX Monoclonal Rabbit Anti-Human PMS2, Clone EP51 Ready-to-Use (Dako Omnis)

GA087/IR087

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Agilent Technologies Singapore (International) Pte Ltd
Manufacturer SRN: SG-MF-000014448
UDI-DI: 05700573004508
Basic UDI-DI: 570057R0301P3007C057901QD
Reference: GA087
EMDN: W0102030199
EMDN description: CANCER ANTIGENS - OTHER
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 31.07.2026 11:54

Manufacturer products Authorised representative products Authorised representative actors View details

FLEX Monoclonal Rabbit Anti-Human MSH6, Clone EP49 Ready-to-Use (Dako Omnis)

GA086/IR086

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Agilent Technologies Singapore (International) Pte Ltd
Manufacturer SRN: SG-MF-000014448
UDI-DI: 05700573004492
Basic UDI-DI: 570057R0301P3007C057801Q8
Reference: GA086
EMDN: W0102030199
EMDN description: CANCER ANTIGENS - OTHER
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 31.07.2026 11:54

Manufacturer products Authorised representative products Authorised representative actors View details

FLEX Monoclonal Mouse Anti-Human MSH2, Clone FE11 Ready-to-Use (Dako Omnis)

GA085/IR085

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Agilent Technologies Singapore (International) Pte Ltd
Manufacturer SRN: SG-MF-000014448
UDI-DI: 05700573004485
Basic UDI-DI: 570057R0301P3007C057701Q3
Reference: GA085
EMDN: W0102030199
EMDN description: CANCER ANTIGENS - OTHER
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 31.07.2026 11:54

Manufacturer products Authorised representative products Authorised representative actors View details

FLEX Monoclonal Mouse Anti-Human MLH1, Clone ES05 Ready-to-Use (Dako Omnis)

GA079/IR079

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Agilent Technologies Singapore (International) Pte Ltd
Manufacturer SRN: SG-MF-000014448
UDI-DI: 05700573003730
Basic UDI-DI: 570057R0301P3007C057601PW
Reference: GA079
EMDN: W0102030199
EMDN description: CANCER ANTIGENS - OTHER
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 31.07.2026 11:54

Manufacturer products Authorised representative products Authorised representative actors View details