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HBA®

BCT-HBA-10

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: CooperSurgical, Inc.
Manufacturer SRN: US-MF-000002607
UDI-DI: 20888937025839
Basic UDI-DI: 08889370TD104PW
Reference: BCT-HBA-10
EMDN: W05039099
EMDN description: DEVICES FOR SAMPLES ANALYSES - OTHER
First on market country: Netherlands
Authorised representative: CooperSurgical Distribution B.V.
Last updated: 16.07.2026 07:45

Manufacturer products Authorised representative products Authorised representative actors View details

Cell-VU Microscope Slides and Coverslips

IVD Class AIVDR 2017/746On the market

Manufacturer: MILLENNIUM SCIENCES, INC
Manufacturer SRN: US-MF-000024011
UDI-DI: 00866093000200
Basic UDI-DI: 08660930002CELLVUXY
Reference: DRM-600
EMDN: W0503900201
EMDN description: MICROSCOPE SLIDES
First on market country: Italy
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 07:00

Manufacturer products Authorised representative products Authorised representative actors View details

ParaProTM SEM

IVD Class AIVDR 2017/746On the marketReagent

Manufacturer: SLMP LLC d.b.a. StatLab Medical Products
Manufacturer SRN: US-MF-000029059
UDI-DI: 00860008410429
Basic UDI-DI: 08600084104PP001F2
Reference: PPSEM
EMDN: W05030599
EMDN description: DEVICES FOR PATOLOGY TESTS - OTHER
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:52

Manufacturer products Authorised representative products Authorised representative actors View details

TissueGuard™ Gel

TissueGuard™ Gel,

IVD Class AIVDR 2017/746On the marketReagent

Manufacturer: SLMP LLC d.b.a. StatLab Medical Products
Manufacturer SRN: US-MF-000029059
UDI-DI: 00850049730143
Basic UDI-DI: 0850049730EM001MT
Reference: TG12
EMDN: W05030599
EMDN description: DEVICES FOR PATOLOGY TESTS - OTHER
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:30

Manufacturer products Authorised representative products Authorised representative actors View details

ClearPrep

Clear Prep Cytology System

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Resolution Biomedical, Inc.
Manufacturer SRN: US-MF-000029623
UDI-DI: 00850046768002
Basic UDI-DI: 0850046768CPBS
Reference: CP11006
EMDN: W05039099
EMDN description: DEVICES FOR SAMPLES ANALYSES - OTHER
First on market country: Poland
Authorised representative: Cost Saving Solutions Europe Ltd
Last updated: 16.07.2026 06:29

Manufacturer products Authorised representative products Authorised representative actors View details

00850033297003

KOVA Plastics Urinalysis System

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

Manufacturer: Alltrista Plastics LLC
Manufacturer SRN: US-MF-000021674
UDI-DI: 00850033297003
Basic UDI-DI: 0850033297KOVAPLASTICSF5
Reference: 87135E
EMDN: W0503020199
EMDN description: PIPETTES - OTHER
First on market country: Germany
Authorised representative: Advena Limited
Last updated: 16.07.2026 06:22

Manufacturer products Authorised representative products Authorised representative actors View details

MammaPrint BluePrint Breast Cancer Recurrence and Molecular Subtyping Kit

MammaPrint BluePrint NGS Kit

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Agendia N.V
Manufacturer SRN: NL-MF-000011684
UDI-DI: 00850024841352
Basic UDI-DI: 085002484193128042
Reference: 931280
EMDN: W05039099
EMDN description: DEVICES FOR SAMPLES ANALYSES - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 16.07.2026 06:20

Manufacturer products View details

BluePrint FFPE microarray

BluePrint Diagnostic Microarray

IVD Class CIVDR 2017/746On the marketProfessional testing

Manufacturer: Agendia N.V
Manufacturer SRN: NL-MF-000011684
UDI-DI: 00850024841338
Basic UDI-DI: 0850024841BlueprintBB
Reference: NA (Centralized Lab Product)
EMDN: W05039099
EMDN description: DEVICES FOR SAMPLES ANALYSES - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 06:20

Manufacturer products View details

MammaPrint FFPE microarray

MammaPrint Diagnostic Microarray

IVD Class CIVDR 2017/746On the marketProfessional testing

Manufacturer: Agendia N.V
Manufacturer SRN: NL-MF-000011684
UDI-DI: 00850024841321
Basic UDI-DI: 0850024841MammaprintK9
Reference: NA (Centralized Lab Product)
EMDN: W05039099
EMDN description: DEVICES FOR SAMPLES ANALYSES - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 06:20

Manufacturer products View details

Streck

230200

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: Streck
Manufacturer SRN: US-MF-000013009
UDI-DI: 00844509001898
Basic UDI-DI: 08445090SPVCQ4
Reference: 230200
EMDN: W05039099
EMDN description: DEVICES FOR SAMPLES ANALYSES - OTHER
First on market country: Germany
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:20

Manufacturer products Authorised representative products Authorised representative actors View details

Streck

230202

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: Streck
Manufacturer SRN: US-MF-000013009
UDI-DI: 00844509001867
Basic UDI-DI: 08445090SPCWT
Reference: 230202
EMDN: W05039099
EMDN description: DEVICES FOR SAMPLES ANALYSES - OTHER
First on market country: Germany
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:20

Manufacturer products Authorised representative products Authorised representative actors View details

Ease-Eject Sampler

Osmometer Accessories

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Advanced Instruments, LLC
Manufacturer SRN: US-MF-000027205
UDI-DI: 00816068020504
Basic UDI-DI: 081606802OSMOACCSY5
Reference: 3M0825
EMDN: W0503020199
EMDN description: PIPETTES - OTHER
First on market country: Netherlands
Authorised representative: WMDE B.V.
Last updated: 16.07.2026 04:20

Manufacturer products Authorised representative products Authorised representative actors View details

Caplugs/Evergreen

Serum Cups

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Caplugs, Inc.
Manufacturer SRN: US-MF-000036523
UDI-DI: 00810044200041
Basic UDI-DI: 081004420SCJX
Reference: 127-1235-010
EMDN: W0503010280
EMDN description: SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER ACCESSORIES
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 03:38

Manufacturer products Authorised representative products Authorised representative actors View details

SlideMate™ Plus Adhesion Microscope Slides

Microscope Slides

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: New Erie Scientific LLC
Manufacturer SRN: US-MF-000008165
UDI-DI: 00810041331335
Basic UDI-DI: 081004133NES001MN
Reference: TT-40418218-PS-W
EMDN: W0503900201
EMDN description: MICROSCOPE SLIDES
First on market country: Netherlands
Authorised representative: Epredia Netherlands B.V.
Last updated: 16.07.2026 03:38

Manufacturer products Authorised representative products Authorised representative actors View details

B-Cyto microscope slides 50 pcs

Microscope Slides

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Bio-Optica Milano S.p.A.
Manufacturer SRN: IT-MF-000027525
UDI-DI: 08055672950001
Basic UDI-DI: 080556729W0503900201N5
Reference: 09-3001
EMDN: W0503900201
EMDN description: MICROSCOPE SLIDES
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 03:32

Manufacturer products View details

08034120273145

MANUAL SLIDE STAINING SET

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Bio-Optica Milano S.p.A.
Manufacturer SRN: IT-MF-000027525
UDI-DI: 08034120273145
Basic UDI-DI: 080341202W05039099EM
Reference: 10-44
EMDN: W05039099
EMDN description: DEVICES FOR SAMPLES ANALYSES - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 03:31

Manufacturer products View details

08034120272551

Coverglasses

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Bio-Optica Milano S.p.A.
Manufacturer SRN: IT-MF-000027525
UDI-DI: 08034120272551
Basic UDI-DI: 080341202W0503900202Q2
Reference: 09-2040
EMDN: W0503900202
EMDN description: MICROSCOPE SLIDES COVERSLIP
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 03:31

Manufacturer products View details

08034120272445

Microscope slides

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Bio-Optica Milano S.p.A.
Manufacturer SRN: IT-MF-000027525
UDI-DI: 08034120272445
Basic UDI-DI: 080341202W0503900201PY
Reference: 09-1000TB
EMDN: W0503900201
EMDN description: MICROSCOPE SLIDES
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 03:31

Manufacturer products View details

08034120271882

Embedding cassettes for histology for printers

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Bio-Optica Milano S.p.A.
Manufacturer SRN: IT-MF-000027525
UDI-DI: 08034120271882
Basic UDI-DI: 080341202W05030501C4
Reference: 07-9700
EMDN: W05030501
EMDN description: INCLUSION DEVICES, CASSETTES
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 03:31

Manufacturer products View details

Dual Cytocuvette High Absorption

Dual Cytocuvette

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Bio-Optica Milano S.p.A.
Manufacturer SRN: IT-MF-000027525
UDI-DI: 08033976237158
Basic UDI-DI: 080339762W0503010203DD
Reference: 14-070
EMDN: W0503010203
EMDN description: SAMPLES ANALYSES, PLASTIC CUVETTES
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 03:31

Manufacturer products View details