- Manufacturer
- Hologic
- Manufacturer SRN
- US-MF-000001646
- UDI-DI
- 15420045517516
- Basic UDI-DI
- 54200455DIAGPFGIEXPBACUK
- Reference
- PRD-07122
- EMDN
- W0105070504
- EMDN description
- GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
- First on market country
- -
- Authorised representative
- Hologic BV
- Last updated
- 02.07.2026 06:32
Public EUDAMED Search
EUDAMED Device Search
A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.
Last updated
17.07.2026 04:53
Sync status
Successful
Device
2835433
Actor
47412
Certificate
3100
IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use
Aptima CMV Quant Assay Calibrator
Aptima CMV Quant Assay
IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use
- Manufacturer
- Hologic
- Manufacturer SRN
- US-MF-000001646
- UDI-DI
- 15420045514577
- Basic UDI-DI
- 54200455DIAGAPTCMVAP
- Reference
- PRD-05075
- EMDN
- W0105080908
- EMDN description
- STANDARDS AND CALIBRATORS FOR ALL INFECTIONS/ NAT
- First on market country
- Belgium
- Authorised representative
- Hologic BV
- Last updated
- 02.07.2026 04:06
Aptima Combo 2 Assay
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
Aptima CV/TV Assay
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
Aptima BV Assay
Aptima BV Assay
IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use
- Manufacturer
- Hologic
- Manufacturer SRN
- US-MF-000001646
- UDI-DI
- 15420045512023
- Basic UDI-DI
- 54200455DIAGAPTBVRB
- Reference
- PRD-05186
- EMDN
- W0105011699
- EMDN description
- BACTERIOLOGY - NA REAGENTS - OTHER
- First on market country
- Belgium
- Authorised representative
- Hologic BV
- Last updated
- 02.07.2026 04:06
Panther Fusion GBS Assay
Panther Fusion GBS Assay
IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use
- Manufacturer
- Hologic
- Manufacturer SRN
- US-MF-000001646
- UDI-DI
- 15420045510890
- Basic UDI-DI
- 54200455DIAGPFGBSS3
- Reference
- PRD-04484
- EMDN
- W0105011104
- EMDN description
- STREP. B DETECTION BY NA REAGENTS
- First on market country
- Belgium
- Authorised representative
- Hologic BV
- Last updated
- 02.07.2026 04:06
Panther Fusion MRSA Assay
Panther Fusion MRSA Assay
IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use
- Manufacturer
- Hologic
- Manufacturer SRN
- US-MF-000001646
- UDI-DI
- 15420045510401
- Basic UDI-DI
- 54200455DIAGPFMRSADE
- Reference
- PRD-04803
- EMDN
- W0105011203
- EMDN description
- SAPHYLOCOCCAL DETECTION BY NA REAGENTS
- First on market country
- Belgium
- Authorised representative
- Hologic BV
- Last updated
- 02.07.2026 04:06
Aptima HPV Assay
Aptima HPV Assay
IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use
- Manufacturer
- Hologic
- Manufacturer SRN
- US-MF-000001646
- UDI-DI
- 15420045509542
- Basic UDI-DI
- 54200455DIAGAPTHPVBR
- Reference
- 302929
- EMDN
- W0105041002
- EMDN description
- SCREENING HIGH-RISK HPV - NA REAGENTS
- First on market country
- Belgium
- Authorised representative
- Hologic BV
- Last updated
- 02.07.2026 04:06
Panther Fusion Paraflu Assay
Panther Fusion Paraflu Assay
IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use
- Manufacturer
- Hologic
- Manufacturer SRN
- US-MF-000001646
- UDI-DI
- 15420045509306
- Basic UDI-DI
- 54200455DIAGPFPARAFLURZ
- Reference
- PRD-04329
- EMDN
- W0105040504
- EMDN description
- INFLUENZA & PARA INFLUENZA - NA REAGENTS
- First on market country
- Belgium
- Authorised representative
- Hologic BV
- Last updated
- 02.07.2026 04:06
Panther Fusion AdV/hMPV/RV Assay
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
Aptima Mycoplasma genitalium Assay
Aptima Mycoplasma genitalium Assay
IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use
- Manufacturer
- Hologic
- Manufacturer SRN
- US-MF-000001646
- UDI-DI
- 15420045509146
- Basic UDI-DI
- 54200455DIAGAPTMGENY9
- Reference
- PRD-03374
- EMDN
- W010501080302
- EMDN description
- UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS
- First on market country
- Belgium
- Authorised representative
- Hologic BV
- Last updated
- 02.07.2026 04:06
Aptima Transfer Solution
Reagents and Fluids
IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use
- Manufacturer
- Hologic
- Manufacturer SRN
- US-MF-000001646
- UDI-DI
- 15420045508606
- Basic UDI-DI
- 54200455DIAGTRANSPORT6X
- Reference
- 303658
- EMDN
- W0105900201
- EMDN description
- BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
- First on market country
- Belgium
- Authorised representative
- Hologic BV
- Last updated
- 02.07.2026 04:06
Panther Fusion Flu A/B/RSV Assay
Panther Fusion Flu A/B/RSV Assay
IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use
- Manufacturer
- Hologic
- Manufacturer SRN
- US-MF-000001646
- UDI-DI
- 15420045509283
- Basic UDI-DI
- 54200455DIAGPFFLUABRSVWG
- Reference
- PRD-04328
- EMDN
- W0105040504
- EMDN description
- INFLUENZA & PARA INFLUENZA - NA REAGENTS
- First on market country
- Belgium
- Authorised representative
- Hologic BV
- Last updated
- 02.07.2026 04:06
Panther Fusion Internal Control-S
Panther Fusion Internal Control Reagents
IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use
- Manufacturer
- Hologic
- Manufacturer SRN
- US-MF-000001646
- UDI-DI
- 15420045509221
- Basic UDI-DI
- 54200455DIAGPFINTCTRLWV
- Reference
- PRD-04332
- EMDN
- W0105080808
- EMDN description
- ALL INFECTIOUS DISEASES CONTROLS - NAT
- First on market country
- Belgium
- Authorised representative
- Hologic BV
- Last updated
- 02.07.2026 04:06
Aptima Herpes Simplex Viruses 1 & 2 Assay
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
- 15420045507210
- Basic UDI-DI
- 54200455DIAGAPTHSV12S7
- Reference
- PRD-03568
- EMDN
- W0105040311
- EMDN description
- HSV - NA REAGENTS
- First on market country
- Belgium
- Authorised representative
- Hologic BV
- Last updated
- 02.07.2026 04:05
Aptima Controls Kit
Aptima Controls Kit
IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use
- Manufacturer
- Hologic
- Manufacturer SRN
- US-MF-000001646
- UDI-DI
- 15420045506237
- Basic UDI-DI
- 54200455DIAGAPTCTGCCTRL4X
- Reference
- 301110
- EMDN
- W0105080808
- EMDN description
- ALL INFECTIOUS DISEASES CONTROLS - NAT
- First on market country
- Belgium
- Authorised representative
- Hologic BV
- Last updated
- 02.07.2026 04:05
Aptima Trichomonas vaginalis Assay
Aptima Trichomonas vaginalis Assay
IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use
- Manufacturer
- Hologic
- Manufacturer SRN
- US-MF-000001646
- UDI-DI
- 15420045505483
- Basic UDI-DI
- 54200455DIAGAPTTRICHWY
- Reference
- 303163
- EMDN
- W0105050310
- EMDN description
- TRICHOMONAS - NA REAGENTS
- First on market country
- Belgium
- Authorised representative
- Hologic BV
- Last updated
- 02.07.2026 04:05
Aptima Neisseria gonorrhoeae
Aptima Neisseria gonorrhoeae Assay
IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use
- Manufacturer
- Hologic
- Manufacturer SRN
- US-MF-000001646
- UDI-DI
- 15420045505421
- Basic UDI-DI
- 54200455DIAGAPTGCQL
- Reference
- 302927
- EMDN
- W0105010203
- EMDN description
- GONOCOCCAL DETECTION BY NA REAGENTS
- First on market country
- Belgium
- Authorised representative
- Hologic BV
- Last updated
- 02.07.2026 04:05
Aptima Chlamydia trachomatis Assay
Aptima Chlamydia trachomatis Assay
IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use
- Manufacturer
- Hologic
- Manufacturer SRN
- US-MF-000001646
- UDI-DI
- 15420045505407
- Basic UDI-DI
- 54200455DIAGAPTCTRA
- Reference
- 302925
- EMDN
- W0105010117
- EMDN description
- CHLAMYDIA TRACHOMATIS DETECTION BY NA REAGENTS
- First on market country
- Belgium
- Authorised representative
- Hologic BV
- Last updated
- 02.07.2026 04:05
Aptima Specimen Transfer Kit
Collection, Transport and Lysis Kits
IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use
- Manufacturer
- Hologic
- Manufacturer SRN
- US-MF-000001646
- UDI-DI
- 15420045500297
- Basic UDI-DI
- 54200455DIAGCOLLECTVT
- Reference
- 301154C
- EMDN
- W050299
- EMDN description
- DEVICES FOR SAMPLES TRANSPORT - OTHER
- First on market country
- Belgium
- Authorised representative
- Hologic BV
- Last updated
- 02.07.2026 04:05