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23.09.2026 00:13

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476 device results listed.

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C-Peptide CLIA Microparticles

AutoLumo Analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359543460
Basic UDI-DI: 697015090000073HB
Reference: CMG0203
EMDN: W0102060101
EMDN description: C-PEPTIDE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

Manufacturer products Authorised representative products Authorised representative actors View details

Insulin CLIA Microparticles

AutoLumo Analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359543361
Basic UDI-DI: 697015090000072H9
Reference: CMG0103
EMDN: W0102060103
EMDN description: INSULIN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

Manufacturer products Authorised representative products Authorised representative actors View details

C-Peptide(CLIA)

105-005667-00、105-005684-00、105-005918-00

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

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053157612
Basic UDI-DI: 69449040004L-C-Peptide*NZ
Reference: 105-064663-00
EMDN: W0102060101
EMDN description: C-PEPTIDE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

Insulin (CLIA)

105-005666-00、105-005683-00、105-005917-00

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

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053156516
Basic UDI-DI: 69449040004L-Insulin***FX
Reference: 105-064662-00
EMDN: W0102060103
EMDN description: INSULIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:53

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iFlash-GADA Ⅲ

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912737964
Basic UDI-DI: 692591270327HL
Reference: C86368
EMDN: W0102060105
EMDN description: GAD II ANTIBODIES AND OTHER ICA
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:37

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-ZnT8A

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912718987
Basic UDI-DI: 692591270055HA
Reference: C89051G
EMDN: W0102060199
EMDN description: DIABETES ASSAYS - 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-IA-2A

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912718963
Basic UDI-DI: 692591270053H6
Reference: C89049G
EMDN: W0102060106
EMDN description: THYROSIN PHOSPHATASE IA2 ANTIBODIES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:32

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-ICA

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912718888
Basic UDI-DI: 692591270054H8
Reference: C89050G
EMDN: W0102060108
EMDN description: ISLET CELL AB
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:32

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-Insulin

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912718871
Basic UDI-DI: 692591270047HB
Reference: C86036
EMDN: W0102060103
EMDN description: INSULIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:32

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iFlash-Adiponectin

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912718697
Basic UDI-DI: 692591270049HF
Reference: C86051
EMDN: W0102060199
EMDN description: DIABETES ASSAYS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-IAA

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912718680
Basic UDI-DI: 692591270052H4
Reference: C89048G
EMDN: W0102060104
EMDN description: INSULIN ANTIBODY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-C-Peptide

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912718642
Basic UDI-DI: 692591270048HD
Reference: C86037
EMDN: W0102060101
EMDN description: C-PEPTIDE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-GADA

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912718635
Basic UDI-DI: 692591270051H2
Reference: C89047G
EMDN: W0102060105
EMDN description: GAD II ANTIBODIES AND OTHER ICA
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

Celltac chemi HbA1c N HA-421W

GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: NIHON KOHDEN CORPORATION
Manufacturer SRN: JP-MF-000019022
UDI-DI: 04931921008348
Basic UDI-DI: 4931921IVD0013NS
Reference: HA-421W
EMDN: W0102060109
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)
First on market country: Germany
Authorised representative: NIHON KOHDEN EUROPE GmbH
Last updated: 31.07.2026 07:22

Manufacturer products Authorised representative products Authorised representative actors View details

C-peptide IRMA KIT

IM3639

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590220075
Basic UDI-DI: 150995905IM36396M
Reference: IM3639
EMDN: W0102060101
EMDN description: C-PEPTIDE
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:45

Manufacturer products View details

Albumin RIA KIT

Immunoassay, IM3251

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590218799
Basic UDI-DI: 150995905IM32515P
Reference: IM3251
EMDN: W0102060199
EMDN description: DIABETES ASSAYS - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:45

Manufacturer products View details

Insulin(e) IRMA KIT

IM3210

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590218744
Basic UDI-DI: 150995905IM321059
Reference: Im3210
EMDN: W0102060103
EMDN description: INSULIN
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:45

Manufacturer products View details

Access Ultrasensitive Insulin (Reagent Pack)

33410

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590230623
Basic UDI-DI: 150995901AccuInsEX
Reference: 33410
EMDN: W0102060103
EMDN description: INSULIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:34

Manufacturer products Authorised representative products Authorised representative actors View details

Adiponectin

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060147126988
Basic UDI-DI: B-86060147126988
Reference: N908ADP
EMDN: W0102060199
EMDN description: DIABETES ASSAYS - OTHER
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 30.07.2026 02:29

Manufacturer products Authorised representative products Authorised representative actors View details

GAD

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060147181406
Basic UDI-DI: B-86060147181406
Reference: N2804GAD
EMDN: W0102060105
EMDN description: GAD II ANTIBODIES AND OTHER ICA
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 29.07.2026 09:19

Manufacturer products Authorised representative products Authorised representative actors View details