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Anti-CCP

IVD generalNot specifiedOn the marketSingle use

Manufacturer: GA Generic Assays GmbH
Manufacturer SRN: DE-MF-000032990
UDI-DI: 04250310703962
Basic UDI-DI: B-04250310703962
Reference: 3665
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Germany
Authorised representative: -
Last updated: 01.08.2026 13:58

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

In vitro Diagnostic Kit for Myoglobin (Chemiluminescence Assay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656863
Basic UDI-DI: B-00810173656863
Reference: 1MYOB02
EMDN: W01021304
EMDN description: MYOGLOBIN
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

In vitro Diagnostic Kit for Myoglobin (Chemiluminescence Assay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656856
Basic UDI-DI: B-00810173656856
Reference: 1MYOB01
EMDN: W01021304
EMDN description: MYOGLOBIN
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

In vitro Diagnostic Kit for High sensitivity Troponin T (Chemiluminescence Assay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656849
Basic UDI-DI: B-00810173656849
Reference: 1CTNTB02
EMDN: W01021306
EMDN description: TROPONIN I/T
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

In vitro Diagnostic Kit for High sensitivity Troponin T (Chemiluminescence Assay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656832
Basic UDI-DI: B-00810173656832
Reference: 1CTNTB01
EMDN: W01021306
EMDN description: TROPONIN I/T
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

Easy@Home Digital Pregnancy Rapid Test

DC811

IVD self-testing devicesIVDDOn the marketAnimal tissuesInstrumentReagentSelf testingSingle use

Manufacturer: Guangzhou Decheng Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000013536
UDI-DI: 00810038637884
Basic UDI-DI: B-00810038637884
Reference: 0811S7X002
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 01.08.2026 10:30

Manufacturer products Authorised representative products Authorised representative actors View details

++B261CANVD510KZ

96 Tests

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Diagnostics Biochem Canada Inc.
Manufacturer SRN: CA-MF-000032449
UDI-DI: ++B261CANVD510KZ
Basic UDI-DI: B-++B261CANVD510KZ
Reference: CAN-VD-510
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 01.08.2026 01:41

Manufacturer products Authorised representative products Authorised representative actors View details

++B261CANTSH408068

96 Tests

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Diagnostics Biochem Canada Inc.
Manufacturer SRN: CA-MF-000032449
UDI-DI: ++B261CANTSH408068
Basic UDI-DI: B-++B261CANTSH408068
Reference: CAN-TSH-4080
EMDN: W01020410
EMDN description: THYROID STIMULATING HORMONE
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 01.08.2026 01:40

Manufacturer products Authorised representative products Authorised representative actors View details

++B261CANTE300K5

CAN-TE-300

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Diagnostics Biochem Canada Inc.
Manufacturer SRN: CA-MF-000032449
UDI-DI: ++B261CANTE300K5
Basic UDI-DI: B-++B261CANTE300K5
Reference: CAN-TE-300
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 01.08.2026 01:40

Manufacturer products Authorised representative products Authorised representative actors View details

++B261CANTE250KF

CAN-TE-250

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Diagnostics Biochem Canada Inc.
Manufacturer SRN: CA-MF-000032449
UDI-DI: ++B261CANTE250KF
Basic UDI-DI: B-++B261CANTE250KF
Reference: CAN-TE-250
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 01.08.2026 01:40

Manufacturer products Authorised representative products Authorised representative actors View details

++B261CANT44240FL

96 Tests

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Diagnostics Biochem Canada Inc.
Manufacturer SRN: CA-MF-000032449
UDI-DI: ++B261CANT44240FL
Basic UDI-DI: B-++B261CANT44240FL
Reference: CAN-T4-4240
EMDN: W01020407
EMDN description: THYROXINE
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 01.08.2026 01:40

Manufacturer products Authorised representative products Authorised representative actors View details

++B261CANT34220F3

96 Tests

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Diagnostics Biochem Canada Inc.
Manufacturer SRN: CA-MF-000032449
UDI-DI: ++B261CANT34220F3
Basic UDI-DI: B-++B261CANT34220F3
Reference: CAN-T3-4220
EMDN: W01020405
EMDN description: TRIIODOTHYRONINE
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 01.08.2026 01:40

Manufacturer products Authorised representative products Authorised representative actors View details

++B261CANSHBG4010D9

96 Tests

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Diagnostics Biochem Canada Inc.
Manufacturer SRN: CA-MF-000032449
UDI-DI: ++B261CANSHBG4010D9
Basic UDI-DI: B-++B261CANSHBG4010D9
Reference: CAN-SHBG-4010
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 01.08.2026 01:40

Manufacturer products Authorised representative products Authorised representative actors View details