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Vitamin B12 Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Life Science, LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: 10850076346406
Basic UDI-DI: B-10850076346406
Reference: CIVB12-301a
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 24.09.2026 16:20

Manufacturer products Authorised representative products Authorised representative actors View details

MutaPLATE® TPMT (TM)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598010772
Basic UDI-DI: B-04050598010772
Reference: KF191332
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 16:20

Manufacturer products View details

Vitamin B12 Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Life Science, LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: 20850076346403
Basic UDI-DI: B-20850076346403
Reference: CIVB12-301a
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 24.09.2026 16:20

Manufacturer products Authorised representative products Authorised representative actors View details

25-OH-Vitamin D Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Life Science, LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: 10850076346413
Basic UDI-DI: B-10850076346413
Reference: CIVD-301a
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 24.09.2026 16:20

Manufacturer products Authorised representative products Authorised representative actors View details

PreventID® CC

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598008205
Basic UDI-DI: B-04050598008205
Reference: KST40110TP
EMDN: W0103010601
EMDN description: HAEMOGLOBIN (HB)
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 16:20

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25-OH-Vitamin D Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Life Science, LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: 20850076346410
Basic UDI-DI: B-20850076346410
Reference: CIVD-301a
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 24.09.2026 16:20

Manufacturer products Authorised representative products Authorised representative actors View details

N-MID Osteocalcin Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Life Science, LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: 10850076346420
Basic UDI-DI: B-10850076346420
Reference: CIMID(N)-301a
EMDN: W0102060311
EMDN description: OSTEOCALCINE
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 24.09.2026 16:20

Manufacturer products Authorised representative products Authorised representative actors View details

MutaPLEX® Borrelia, PCR

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598003040
Basic UDI-DI: B-04050598003040
Reference: KG1917032
EMDN: W0105010605
EMDN description: LYME DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 16:20

Manufacturer products View details

N-MID Osteocalcin Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Life Science, LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: 20850076346427
Basic UDI-DI: B-20850076346427
Reference: CIMID(N)-301a
EMDN: W0102060311
EMDN description: OSTEOCALCINE
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 24.09.2026 16:20

Manufacturer products Authorised representative products Authorised representative actors View details

MutaPLATE® TPMT (TM)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598010765
Basic UDI-DI: B-04050598010765
Reference: KF191396
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 16:20

Manufacturer products View details

Parathyroid Hormone Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Life Science, LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: 10850076346437
Basic UDI-DI: B-10850076346437
Reference: CIPTH-301a
EMDN: W0102060312
EMDN description: PARATHYROID HORMONE INTACT
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 24.09.2026 16:20

Manufacturer products Authorised representative products Authorised representative actors View details

Parathyroid Hormone Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Life Science, LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: 20850076346434
Basic UDI-DI: B-20850076346434
Reference: CIPTH-301a
EMDN: W0102060312
EMDN description: PARATHYROID HORMONE INTACT
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 24.09.2026 16:20

Manufacturer products Authorised representative products Authorised representative actors View details

Hemoglobin A1c Test Kit(BoronateFluorescence Quenching Technology)

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384631104
Basic UDI-DI: B-06938384631104
Reference: L-100103
EMDN: W01010699
EMDN description: CLIN. CHEM. RT & POC - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 16:20

Manufacturer products Authorised representative products Authorised representative actors View details

Tuberculosis Interferon-Gamma Release Assay Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Life Science, LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: 20850076346441
Basic UDI-DI: B-20850076346441
Reference: CCTBIG-401a
EMDN: W0105010704
EMDN description: TB-IGRA (INTERFERON-‐GAMMA-‐RELEASE ASSAY)
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 24.09.2026 16:20

Manufacturer products Authorised representative products Authorised representative actors View details

MutaPLEX® Borrelia, PCR

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598002425
Basic UDI-DI: B-04050598002425
Reference: KG1917096
EMDN: W0105010605
EMDN description: LYME DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 16:20

Manufacturer products View details

MutaPLEX® Blastocystis, PCR

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598005532
Basic UDI-DI: B-04050598005532
Reference: KG191896
EMDN: W0105011699
EMDN description: BACTERIOLOGY - NA REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 16:19

Manufacturer products View details

Histamin (EDTA-Plasma, Urin) ELISA

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598001114
Basic UDI-DI: B-04050598001114
Reference: K 8212
EMDN: W01020209
EMDN description: HISTAMINE
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 16:19

Manufacturer products View details

ImmuTube® Vitamin D duo

ImmuTube® Vitamin D duo LC-MS/MS kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598007840
Basic UDI-DI: B-04050598007840
Reference: KM1310
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 16:19

Manufacturer products View details

Histamine (Stool) ELISA

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598001121
Basic UDI-DI: B-04050598001121
Reference: K 8213
EMDN: W01020209
EMDN description: HISTAMINE
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 16:18

Manufacturer products View details

08809408862812

Surearly SMART Ovulation Hormone Test

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitReagentSelf testingSingle use

Manufacturer: Sugentech, Inc.
Manufacturer SRN: KR-MF-000023952
UDI-DI: 08809408862812
Basic UDI-DI: 88094088SLHR-001AC
Reference: SLHR010E
EMDN: W0102050199
EMDN description: FERTILITY FUNCTION HORMONES - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 24.09.2026 16:14

Manufacturer products Authorised representative products Authorised representative actors View details