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220 device results listed.

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MyoSure MANUAL Tissue Removal Device

Class IIaMDR 2017/745On the marketDirect markingSingle useSterile

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000003310
UDI-DI: 15420045507937
Basic UDI-DI: 54200455GSSMANUALTRDT8
Reference: 20-401ML
EMDN: Z12080204
EMDN description: MORCELLATORS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:05

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Brevera Breast Biopsy System with CorLumina Imaging Technology

Brevera Breast Biopsy System

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000045852
UDI-DI: 15420045507517
Basic UDI-DI: 54200455BREVERASYSTA
Reference: BREV100
EMDN: A01020199
EMDN description: NEEDLES AND KITS FOR HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES - OTHER
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:05

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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

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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

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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

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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

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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

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MyoSure Control Unit

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000003310
UDI-DI: 15420045505124
Basic UDI-DI: 54200455GSSMYOSURECTRL5B
Reference: 10-550
EMDN: Z12080204
EMDN description: MORCELLATORS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:05

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MyoSure REACH Tissue Removal Device

MyoSure REACH Tissue Removal Device; MyoSure LITE Tissue Removal Device; MyoSure XL Tissue Removal Device; MyoSure XL Tissue Removal Device for Fluent

Class IIaMDR 2017/745On the marketDirect markingSingle useSterile

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000003310
UDI-DI: 15420045504530
Basic UDI-DI: 54200455GSSMYOSURETRDQK
Reference: 10-401FC
EMDN: Z12080204
EMDN description: MORCELLATORS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:05

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ATEC Canister

ATEC and Eviva Breast Biopsy and Excision System

Class IMDR 2017/745On the marketSingle use

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000045852
UDI-DI: 15420045503182
Basic UDI-DI: 54200455ATECEVIVACCESS8K
Reference: ATEC Canister
EMDN: A010299
EMDN description: BIOPSY NEEDLES AND KITS - OTHER
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:05

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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

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Aptima Auto Detect Kit

Reagents and Fluids

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045500273
Basic UDI-DI: 54200455DIAGFLUIDSBG
Reference: 303013
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:05

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: 15420045500112
Basic UDI-DI: 54200455DIAGAPTHPVGTVK
Reference: 303236
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:05

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Panther Fusion Internal Control-X

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

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Panther Fusion Internal Control-B

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

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Aptima Specimen Diluent

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

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

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

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