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618 device results listed.

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Pepsinogen I assay (CLIA)

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7C16DR
Basic UDI-DI: B-7C16DR
Reference: 7C16V1-B-EU, 7C16U1-B-EU, 7C16P1-B-EU
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 12.07.2026 09:27

Manufacturer products Authorised representative products Authorised representative actors View details

D-35276

Pepsinogen II Quantitative Detection KIT (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-35276
Basic UDI-DI: B-35276
Reference: /
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 18:37

Manufacturer products Authorised representative products Authorised representative actors View details

D-35174

Pepsinogen I Quantitative Detection KIT (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-35174
Basic UDI-DI: B-35174
Reference: /
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 18:37

Manufacturer products Authorised representative products Authorised representative actors View details

D-3326Y

Procalcitonin Quantitative Detection KIT (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-3326Y
Basic UDI-DI: B-3326Y
Reference: /
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 18:26

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: 20850076346106
Basic UDI-DI: B-20850076346106
Reference: CDPCT-401a
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 15:02

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-Gastrin-17

IVD Class BNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912719427
Basic UDI-DI: 692591270157HK
Reference: C86055-L
EMDN: W0102069001
EMDN description: GASTRIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 13:48

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-Gastrin-17

IVD Class BNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912721192
Basic UDI-DI: 692591270157HK
Reference: C86055-S
EMDN: W0102069001
EMDN description: GASTRIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 13:48

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-PCT

IVD Class CNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912722991
Basic UDI-DI: 692591270050GY
Reference: C86317
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 13:48

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-PG I

IVD Class BNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912723844
Basic UDI-DI: 692591270095HN
Reference: C86040-S
EMDN: W0102069006
EMDN description: PEPSINOGEN
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-PG II

IVD Class BNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912723851
Basic UDI-DI: 692591270096HQ
Reference: C86041-S
EMDN: W0102069006
EMDN description: PEPSINOGEN
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

PCT/IL-6 Rapid Test (FIA)

P232102

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle useSterile

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698600170
Basic UDI-DI: B-16972698600170
Reference: P232102
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

TruVue

PG I/PG II Test (FIA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763709
Basic UDI-DI: B-15065023763709
Reference: TV20032
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Czechia
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:36

Manufacturer products Authorised representative products Authorised representative actors View details

TruVue

PCT Test (FIA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763488
Basic UDI-DI: B-15065023763488
Reference: TV20010
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:35

Manufacturer products Authorised representative products Authorised representative actors View details

Melatonin Reagent Set

1280 M MEL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Diagnotix B.V.
Manufacturer SRN: NL-MF-000000236
UDI-DI: D-1280MMELLD
Basic UDI-DI: B-1280MMELLD
Reference: 1280 M MEL
EMDN: W0102069003
EMDN description: MELATONINE
First on market country: Netherlands
Authorised representative: -
Last updated: 11.07.2026 05:56

Manufacturer products View details

D-11Q8C

Pepsinogens ⅡAssay Kit (Latex Immunoturbidimetric Method)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-11Q8C
Basic UDI-DI: B-11Q8C
Reference: /
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 05:52

Manufacturer products Authorised representative products Authorised representative actors View details

D-11P8A

PepsinogensⅠAssay Kit (Latex Immunoturbidimetric Method)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-11P8A
Basic UDI-DI: B-11P8A
Reference: /
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 05:52

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: 10850076346109
Basic UDI-DI: B-10850076346109
Reference: CDPCT-401a
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 04:36

Manufacturer products Authorised representative products Authorised representative actors View details

FREND PCT

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540054
Basic UDI-DI: B-08809317540054
Reference: FRPC 025
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Cyprus
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 13:41

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Testosterone II

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414591148
Basic UDI-DI: 0405686901634VR
Reference: 10696863
EMDN: W0102069099
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES - OTHER
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 10.07.2026 06:46

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Testosterone II (TSTII)

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414600215
Basic UDI-DI: 0405686901634VR
Reference: 10995707
EMDN: W0102069099
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES - OTHER
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 10.07.2026 06:46

Manufacturer products Authorised representative products Authorised representative actors View details