Public EUDAMED Search

EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

TR EN

Last updated

08.07.2026 16:23

Sync status

Successful

Device

2717361

Actor

47340

Certificate

3053

Filters

Show filters

Active filter:Manufacturer SRN:US-MF-000001646

84 device results listed.

Page 3 / 5

CSV XML

Blood Transport Medium

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045510944
Basic UDI-DI: 54200455DIAGTRANSPORT6X
Reference: PRD-04944
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: -
Authorised representative: Hologic BV
Last updated: 30.06.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

Specimen Transport Medium

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045510920
Basic UDI-DI: 54200455DIAGTRANSPORT6X
Reference: PRD-04423
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: -
Authorised representative: Hologic BV
Last updated: 30.06.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima Whole Blood Diluent

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045514591
Basic UDI-DI: 54200455DIAGTRANSPORT6X
Reference: PRD-06783
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: -
Authorised representative: Hologic BV
Last updated: 30.06.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

Panther Fusion GBS Controls Kit

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045510906
Basic UDI-DI: 54200455DIAGPFGBSS3
Reference: PRD-04485
EMDN: W0105011104
EMDN description: STREP. B DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima Chlamydia trachomatis Assay

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045505414
Basic UDI-DI: 54200455DIAGAPTCTRA
Reference: 302925
EMDN: W0105010117
EMDN description: CHLAMYDIA TRACHOMATIS DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima Combo 2 Assay

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045512900
Basic UDI-DI: 54200455DIAGAPTCOMBO2P8
Reference: PRD-05576
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima Combo 2 Assay

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045512849
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: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima Combo 2 Assay

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045512894
Basic UDI-DI: 54200455DIAGAPTCOMBO2P8
Reference: PRD-05576
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima HPV 16 18/45 Genotype Assay

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045500129
Basic UDI-DI: 54200455DIAGAPTHPVGTVK
Reference: 303236
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima Neisseria gonorrhoeae

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045505438
Basic UDI-DI: 54200455DIAGAPTGCQL
Reference: 302927
EMDN: W0105010203
EMDN description: GONOCOCCAL DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima Trichomonas vaginalis Assay

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045505490
Basic UDI-DI: 54200455DIAGAPTTRICHWY
Reference: 303163
EMDN: W0105050310
EMDN description: TRICHOMONAS - NA REAGENTS
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima Trichomonas vaginalis Assay

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045505506
Basic UDI-DI: 54200455DIAGAPTTRICHWY
Reference: 303209
EMDN: W0105050310
EMDN description: TRICHOMONAS - NA REAGENTS
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima Trichomonas vaginalis Assay

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045505513
Basic UDI-DI: 54200455DIAGAPTTRICHWY
Reference: 303209
EMDN: W0105050310
EMDN description: TRICHOMONAS - NA REAGENTS
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima Trichomonas vaginalis Controls Kit

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045505766
Basic UDI-DI: 54200455DIAGAPTTRICHWY
Reference: 302807
EMDN: W0105050310
EMDN description: TRICHOMONAS - NA REAGENTS
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima Herpes Simplex Viruses 1 & 2 Assay

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045507227
Basic UDI-DI: 54200455DIAGAPTHSV12S7
Reference: PRD-03568
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima Herpes Simplex Viruses 1 & 2 Assay Controls Kit

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045507234
Basic UDI-DI: 54200455DIAGAPTHSV12S7
Reference: PRD-03569
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima Mycoplasma genitalium Assay

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045509153
Basic UDI-DI: 54200455DIAGAPTMGENY9
Reference: PRD-03374
EMDN: W010501080302
EMDN description: UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

Panther Fusion Flu A/B/RSV Assay Controls Kit

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045509313
Basic UDI-DI: 54200455DIAGPFFLUABRSVWG
Reference: PRD-04336
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

Panther Fusion AdV/hMPV/RV Assay Controls Kit

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045509320
Basic UDI-DI: 54200455DIAGPFAdVhMPVRVZ2
Reference: PRD-04338
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima HPV Assay

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045509559
Basic UDI-DI: 54200455DIAGAPTHPVBR
Reference: 302929
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details