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IVD Class AIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: AB ANALITICA srl
Manufacturer SRN: IT-MF-000032625
UDI-DI: 08053303092533
Basic UDI-DI: 803362278GINCcr00000000PQ
Reference: 05-79-A
EMDN: W0105900103
EMDN description: SUPPLEMENTAL NA REAGENTS
First on market country: Italy
Authorised representative: -
Last updated: 24.09.2026 15:13

Manufacturer products View details

08033629921441

Estrazione DNA da sangue

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Nuclear Laser Medicine srl
Manufacturer SRN: IT-MF-000025709
UDI-DI: 08033629921441
Basic UDI-DI: 803362992AA1319UN
Reference: AA1319/96
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 24.09.2026 15:11

Manufacturer products View details

Glycosylated Hemoglobin Test Reagent Kit (HPLC)

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384631319
Basic UDI-DI: B-06938384631319
Reference: L-600108
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 15:07

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Calibrator Kit

IVD generalNot specifiedOn the market

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384631029
Basic UDI-DI: B-06938384631029
Reference: L-500301
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 15:07

Manufacturer products Authorised representative products Authorised representative actors View details

Total Triiodothyronine Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Life Science, LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: 10850076346031
Basic UDI-DI: B-10850076346031
Reference: CKTT3-301a
EMDN: W01020405
EMDN description: TRIIODOTHYRONINE
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 24.09.2026 15:05

Manufacturer products Authorised representative products Authorised representative actors View details

C-Peptide Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Life Science, LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: 10850076346352
Basic UDI-DI: B-10850076346352
Reference: CIPEP(C)-201a
EMDN: W0102060101
EMDN description: C-PEPTIDE
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 24.09.2026 15:05

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Control Kit

IVD generalNot specifiedOn the market

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384631012
Basic UDI-DI: B-06938384631012
Reference: L-500201
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 15:04

Manufacturer products Authorised representative products Authorised representative actors View details

Hemoglobin (A2/F/A1c) Control Kit

IVD generalNot specifiedOn the market

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384631036
Basic UDI-DI: B-06938384631036
Reference: L-500211
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 15:04

Manufacturer products Authorised representative products Authorised representative actors View details

MutaREAL® HFE

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598002555
Basic UDI-DI: B-04050598002555
Reference: KF291032
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 15:04

Manufacturer products View details

Resistell MicroPrep Kit

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Resistell AG
Manufacturer SRN: CH-MF-000039090
UDI-DI: 07649998169097
Basic UDI-DI: 7649998169MicroPrepTM
Reference: Resistell MicroPrep Kit 50
EMDN: W0104010805
EMDN description: BUFFERS
First on market country: Germany
Authorised representative: Veranex Germany GmbH
Last updated: 24.09.2026 15:04

Manufacturer products Authorised representative products Authorised representative actors View details

MutaREAL® HFE

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598002821
Basic UDI-DI: B-04050598002821
Reference: KF291096
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 15:03

Manufacturer products View details

Hemoglobin (A2/F/A1c) Calibrator Kit

IVD generalNot specifiedOn the market

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384631043
Basic UDI-DI: B-06938384631043
Reference: L-500309
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 15:03

Manufacturer products Authorised representative products Authorised representative actors View details

MutaREAL® Cystic Fibrosis

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598010833
Basic UDI-DI: B-04050598010833
Reference: KF290832
EMDN: W0106010101
EMDN description: CYSTIC FIBROSIS
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 15:03

Manufacturer products View details

MutaREAL® Cystic Fibrosis

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598010826
Basic UDI-DI: B-04050598010826
Reference: KF290896
EMDN: W0106010101
EMDN description: CYSTIC FIBROSIS
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 15:03

Manufacturer products View details

PreventID® Dermatophyte

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598015227
Basic UDI-DI: B-04050598015227
Reference: KSTDE001GP5.02
EMDN: W0105060399
EMDN description: MYCOLOGY IMMUNOASSAYS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 15:03

Manufacturer products View details

Lysozym ELISA

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598000445
Basic UDI-DI: B-04050598000445
Reference: K 6901
EMDN: W01010124
EMDN description: LYSOZYME
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 15:03

Manufacturer products View details

MutaREAL® TPMT

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598001688
Basic UDI-DI: B-04050598001688
Reference: KF291332
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 15:03

Manufacturer products View details

PreventID® Dermatophyte

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598015234
Basic UDI-DI: B-04050598015234
Reference: KSTDE001GP5.03
EMDN: W0105060399
EMDN description: MYCOLOGY IMMUNOASSAYS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 15:03

Manufacturer products View details

Hemoglobin (A2/F/A1c) Test Reagent Kit (HPLC)

IVD generalNot specifiedOn the market

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384631401
Basic UDI-DI: B-06938384631401
Reference: L-560204
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 15:03

Manufacturer products Authorised representative products Authorised representative actors View details

MutaREAL® TPMT

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598001695
Basic UDI-DI: B-04050598001695
Reference: KF291396
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 15:02

Manufacturer products View details