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119 device results listed.

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Cardiac Marker Test Panel (CTNI/CK-MB/MYO)

Cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSelf testingSingle use

Manufacturer: Abiores Technology (Beijing) Co.,Ltd.
Manufacturer SRN: CN-MF-000022952
UDI-DI: 06958982140211
Basic UDI-DI: B-06958982140211
Reference: AF40-40
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Estonia
Authorised representative: Sungo Cert GmbH
Last updated: 05.08.2026 14:39

Manufacturer products Authorised representative products Authorised representative actors View details

06930317853997

20 tests

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317853997
Basic UDI-DI: B-06930317853997
Reference: DNK-2116-1
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 05.08.2026 14:17

Manufacturer products Authorised representative products Authorised representative actors View details

GastroPanel® Pepsinogen II

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587060200
Basic UDI-DI: B-06419587060200
Reference: 606020
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 05.08.2026 14:08

Manufacturer products View details

GastroPanel® Gastrin-17

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587060354
Basic UDI-DI: B-06419587060354
Reference: 606035
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 05.08.2026 14:08

Manufacturer products View details

06930317861374

20 tests

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317861374
Basic UDI-DI: B-06930317861374
Reference: DNK-2117-1
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 03.08.2026 12:41

Manufacturer products Authorised representative products Authorised representative actors View details

GastroPanel Four-in-Oneᵀᴹ

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587606088
Basic UDI-DI: B-06419587606088
Reference: 606080
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:54

Manufacturer products View details

GastroPanel® Unified

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587064000
Basic UDI-DI: B-06419587064000
Reference: 606400
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:53

Manufacturer products View details

GastroPanel® 𝘏𝘦𝘭𝘪𝘤𝘰𝘣𝘢𝘤𝘵𝘦𝘳 𝘱𝘺𝘭𝘰𝘳𝘪

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587060408
Basic UDI-DI: B-06419587060408
Reference: 606040
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:52

Manufacturer products View details

GastroPanel® Pepsinogen I

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587060101
Basic UDI-DI: B-06419587060101
Reference: 606010
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:52

Manufacturer products View details

Quantitative Analysis Kit for Four Inflammatory Markers (Flowcytometry Fluorescence Method)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656962
Basic UDI-DI: B-00810173656962
Reference: 1IF4B01
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 01.08.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details

Quantitative Analysis Kit for Alpha-fetoprotein and Carcino-embryonic antigen (Flowcytometry Fluorescence Method)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656924
Basic UDI-DI: B-00810173656924
Reference: 1TM2B01
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 01.08.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details

Quantitative Analysis Kit for Pepsinogen I, Pepsinogen II and Gastrin-17(Flowcytometry Fluorescence Method)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656917
Basic UDI-DI: B-00810173656917
Reference: 1GF3B01
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 01.08.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details

Analysis Kit for Fifteen Autoantibodies Spectrum (Flowcytometry Fluorescence Method)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656900
Basic UDI-DI: B-00810173656900
Reference: 1AA15B01
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 01.08.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details

Quantitative Analysis Kit for Six Tumor Markers (Flowcytometry Fluorescence Method)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656894
Basic UDI-DI: B-00810173656894
Reference: 1TM6B01
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 01.08.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details

Quantitative Analysis Kit for Seven Tumor Markers (Flowcytometry Fluorescence Method)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656887
Basic UDI-DI: B-00810173656887
Reference: 1TM7B01
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 01.08.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details

Quantitative Analysis Kit for Three Tumor Markers (Flowcytometry Fluorescence Method)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656870
Basic UDI-DI: B-00810173656870
Reference: 1TM3B01
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 01.08.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer kit (Particle-enhanced Immunoturbidimetric Assay Method)

105-012738-00、105-002236-00、105-002237-00、105-012737-00、105-004497-00、105-004498-00、105-002300-00、105-002301-00

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: 06944904032146
Basic UDI-DI: 69449040004JD-Dimer****Q7
Reference: 105-002236-00
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:43

Manufacturer products Authorised representative products Authorised representative actors View details

Thiolstatus

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598016231
Basic UDI-DI: B-04050598016231
Reference: K 1800DX
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 15:25

Manufacturer products View details

Thiolstatus

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598118003
Basic UDI-DI: B-04050598118003
Reference: K 1800
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 15:25

Manufacturer products View details

LIA-Diabetes-Profile

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: D-TA-L89408G2EE
Basic UDI-DI: B-TA-L89408G2EE
Reference: TA-L89408G2
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 10:54

Manufacturer products Authorised representative products Authorised representative actors View details