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Aptima Combo 2 Assay

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045512832
Basic UDI-DI: 54200455DIAGAPTCOMBO2P8
Reference: PRD-05571
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima CV/TV Assay

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045512061
Basic UDI-DI: 54200455DIAGAPTCVTV2E
Reference: PRD-05189
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

Panther Fusion AdV/hMPV/RV Assay

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045509290
Basic UDI-DI: 54200455DIAGPFAdVhMPVRVZ2
Reference: PRD-04330
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

QIAstat-Dx Respiratory SARS-CoV-2 Panel

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: QIAGEN GmbH
Manufacturer SRN: DE-MF-000004949
UDI-DI: 04053228047438
Basic UDI-DI: 4053228RRPSC2QST0000001PM
Reference: 691215
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Austria
Authorised representative: -
Last updated: 01.07.2026 19:23

Manufacturer products View details

QIAstat-Dx Meningitis/Encephalitis (ME) Panel

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: QIAGEN GmbH
Manufacturer SRN: DE-MF-000004949
UDI-DI: 04053228046097
Basic UDI-DI: 4053228RMEQSTA000000001ML
Reference: 691612
EMDN: W0105070505
EMDN description: MENINGITIS / ENCEPHALITIS INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Austria
Authorised representative: -
Last updated: 01.07.2026 19:23

Manufacturer products View details

04049095210136

RIDA®UNITY CAP Bac

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095210136
Basic UDI-DI: 4049095UN27050000S8
Reference: UN2705
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:52

Manufacturer products View details

04049095210112

RIDA®UNITY Bacterial Stool Panel

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095210112
Basic UDI-DI: 4049095UN24050000QM
Reference: UN2405
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:52

Manufacturer products View details

04049095160615

RIDA®GENE CAP Bac

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095160615
Basic UDI-DI: 4049095PG27050000GN
Reference: PG2705
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:52

Manufacturer products View details

LiquidArray® Gastrointestinal VER 2.0

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055003990
Basic UDI-DI: 40490550300001110TX
Reference: 1910680
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:48

Manufacturer products View details

LiquidArray® MTB-XDR VER 1.0

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055003877
Basic UDI-DI: 40490550300001106U8
Reference: 1880018
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:48

Manufacturer products View details

LiquidArray® Gastrointestinal VER 1.0

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055003846
Basic UDI-DI: 40490550300001092UN
Reference: 1896297
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:48

Manufacturer products View details

03770041419105

60407

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: ADEMTECH
Manufacturer SRN: FR-MF-000048678
UDI-DI: 03770041419105
Basic UDI-DI: 377004141960407CK
Reference: 60405
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 16:16

Manufacturer products View details

03770041419082

60406

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: ADEMTECH
Manufacturer SRN: FR-MF-000048678
UDI-DI: 03770041419082
Basic UDI-DI: 377004141960406CH
Reference: 60406
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 16:16

Manufacturer products View details

03770041419037

60405

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: ADEMTECH
Manufacturer SRN: FR-MF-000048678
UDI-DI: 03770041419037
Basic UDI-DI: 377004141960405CF
Reference: 60405
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 16:16

Manufacturer products View details

BIOSYNEX AMPLIQUICK Fecal Bacteriology

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532678607849
Basic UDI-DI: 353267F00188P98
Reference: 3150046_SEC01
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:27

Manufacturer products View details

BIOSYNEX AMPLIQUICK STI Panel I

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532670103578
Basic UDI-DI: 353267F00204P7T
Reference: 3150070_SEC01
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:25

Manufacturer products View details

Allplex™ NG & DR Assay

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240103685
Basic UDI-DI: 924010SD10367H5
Reference: SD10368Z
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:13

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ NG & DR Assay

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240103678
Basic UDI-DI: 924010SD10367H5
Reference: SD10367X
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:13

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ STI Essential Assay Q(MH,UU)

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240103180
Basic UDI-DI: 924010SD10202G4
Reference: SD10318Z
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:13

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ CT/NG/MG/TV Assay

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240103173
Basic UDI-DI: 924010SD94000KA
Reference: SD10317Z
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:13

Manufacturer products Authorised representative products Authorised representative actors View details