Public EUDAMED Search

EUDAMED Device Search

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

Last updated

23.09.2026 18:59

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227 device results listed.

Page 6 / 12

Panther Fusion Internal Control-X

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IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045510470
Basic UDI-DI: 54200455DIAGPFINTCTRLWV
Reference: PRD-04476
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
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 Internal Control-B

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IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045512924
Basic UDI-DI: 54200455DIAGPFINTCTRLWV
Reference: PRD-06234
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
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 Specimen Diluent

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045509177
Basic UDI-DI: 54200455DIAGTRANSPORT6X
Reference: PRD-03003
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 DBS Extraction Buffer

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045511811
Basic UDI-DI: 54200455DIAGTRANSPORT6X
Reference: PRD-04772
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

Urine Transport Medium

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045510937
Basic UDI-DI: 54200455DIAGTRANSPORT6X
Reference: PRD-04943
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

Blood Transport Medium

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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

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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

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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

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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

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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

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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

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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

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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

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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

Eviva Needle Guide

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Class INot specifiedOn the marketDirect markingSingle useSterile

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000045852
UDI-DI: 15420045504615
Basic UDI-DI: 54200455BRSTSNGTFGK
Reference: EVIVA_NG12R
EMDN: A018002
EMDN description: NEEDLE GUIDES
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

ATEC Breast Biopsy and Excision System Handpiece

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Class IIaNot specifiedOn the marketDirect markingSingle useSterile

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000045852
UDI-DI: 15420045504837
Basic UDI-DI: 54200455ATECEVIVAHANDPCHA
Reference: ATEC 0909-12
EMDN: A018003
EMDN description: NEEDLE INTRODUCERS
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

ATEC Breast Biopsy and Excision System Handpiece

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Class IIaNot specifiedOn the marketDirect markingSingle useSterile

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000045852
UDI-DI: 15420045504844
Basic UDI-DI: 54200455ATECEVIVAHANDPCHA
Reference: ATEC 0909-20
EMDN: A018003
EMDN description: NEEDLE INTRODUCERS
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

ATEC Breast Biopsy and Excision System Handpiece

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Class IIaNot specifiedOn the marketDirect markingSingle useSterile

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000045852
UDI-DI: 15420045504851
Basic UDI-DI: 54200455ATECEVIVAHANDPCHA
Reference: ATEC 0912-12
EMDN: A018003
EMDN description: NEEDLE INTRODUCERS
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

ATEC Breast Biopsy and Excision System Handpiece

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Class IIaNot specifiedOn the marketDirect markingSingle useSterile

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000045852
UDI-DI: 15420045504868
Basic UDI-DI: 54200455ATECEVIVAHANDPCHA
Reference: ATEC 0912-20
EMDN: A018003
EMDN description: NEEDLE INTRODUCERS
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

ATEC Breast Biopsy and Excision System Handpiece

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Class IIaNot specifiedOn the marketDirect markingSingle useSterile

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000045852
UDI-DI: 15420045504882
Basic UDI-DI: 54200455ATECEVIVAHANDPCHA
Reference: ATEC 0914-20
EMDN: A018003
EMDN description: NEEDLE INTRODUCERS
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