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HistoStar Tissue Embedding Center

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shandon Diagnostics Limited
Manufacturer SRN: GB-MF-000008187
UDI-DI: 05051663518208
Basic UDI-DI: 5051663SDL004K8
Reference: A81010034
EMDN: W0202059004
EMDN description: TISSUE EMBEDDING PROCESSORS
First on market country: Netherlands
Authorised representative: Epredia Netherlands B.V.
Last updated: 16.07.2026 09:45

Manufacturer products Authorised representative products Authorised representative actors View details

5 Litre Reagent bottle - Empty (set of 6 bottles)

Revos Tissue Processor

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shandon Diagnostics Limited
Manufacturer SRN: GB-MF-000008187
UDI-DI: 05051663517324
Basic UDI-DI: 5051663SDL001K2
Reference: A78410026
EMDN: W0202059010
EMDN description: TISSUE PROCESSORS
First on market country: Netherlands
Authorised representative: Epredia Netherlands B.V.
Last updated: 16.07.2026 09:45

Manufacturer products Authorised representative products Authorised representative actors View details

INLET HOSE 2.5M LONG

Gemini AS Automatic Stainer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shandon Diagnostics Limited
Manufacturer SRN: GB-MF-000008187
UDI-DI: 05051663504065
Basic UDI-DI: 5051663SDL007KE
Reference: AP14160
EMDN: W0202059002
EMDN description: AUTOMATED SLIDE STAINERS
First on market country: Netherlands
Authorised representative: Epredia Netherlands B.V.
Last updated: 16.07.2026 09:45

Manufacturer products Authorised representative products Authorised representative actors View details

Cryostar NX50 OP

Cryostar NX50 Cryostat

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shandon Diagnostics Limited
Manufacturer SRN: GB-MF-000008187
UDI-DI: 05051663010290
Basic UDI-DI: 5051663SDL015KD
Reference: 957250
EMDN: W0202059003
EMDN description: CRYOSTAT MICROTOMES
First on market country: Netherlands
Authorised representative: Epredia Netherlands B.V.
Last updated: 16.07.2026 09:45

Manufacturer products Authorised representative products Authorised representative actors View details

Cryostar NX70 HOMPD

Cryostar NX70 Cryostat

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shandon Diagnostics Limited
Manufacturer SRN: GB-MF-000008187
UDI-DI: 05051663003834
Basic UDI-DI: 5051663SDL016KF
Reference: 957010L
EMDN: W0202059003
EMDN description: CRYOSTAT MICROTOMES
First on market country: Netherlands
Authorised representative: Epredia Netherlands B.V.
Last updated: 16.07.2026 09:45

Manufacturer products Authorised representative products Authorised representative actors View details

GDxDORCO 35H, HIGH PROFILE

35H, High Profile, 35°, 50-pack

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentSingle use

Manufacturer: GANGDONG GROUP CO., LTD.
Manufacturer SRN: KR-MF-000021347
UDI-DI: 08809772981126
Basic UDI-DI: 08809772981126ZT
Reference: 021-1302-1036
EMDN: W0202059085
EMDN description: VARIOUS PROCESSING INSTRUMENTS FOR HYSTOLOGY / CYTOLOGY - CONSUMABLES
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 07:06

Manufacturer products Authorised representative products Authorised representative actors View details

GDxDORCO 35L, LOW PROFILE

35L, Low Profile, 35°, 50-pack

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentSingle use

Manufacturer: GANGDONG GROUP CO., LTD.
Manufacturer SRN: KR-MF-000021347
UDI-DI: 08809772981034
Basic UDI-DI: 08809772981034ZM
Reference: 021-1302-1035
EMDN: W0202059085
EMDN description: VARIOUS PROCESSING INSTRUMENTS FOR HYSTOLOGY / CYTOLOGY - CONSUMABLES
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 07:06

Manufacturer products Authorised representative products Authorised representative actors View details

ASP Device

ASP System

IVD Class AIVDR 2017/746On the marketHuman tissuesInstrumentProfessional testing

Manufacturer: ASP Health Inc.
Manufacturer SRN: US-MF-000038725
UDI-DI: 00860008222404
Basic UDI-DI: 08600082224ASPMK
Reference: PI-0076558
EMDN: W0202059085
EMDN description: VARIOUS PROCESSING INSTRUMENTS FOR HYSTOLOGY / CYTOLOGY - CONSUMABLES
First on market country: Italy
Authorised representative: CEpartner4U
Last updated: 16.07.2026 06:52

Manufacturer products Authorised representative products Authorised representative actors View details

Ultrasonic tissue processor

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Guangzhou Naturn Medical Devices Co., Ltd.
Manufacturer SRN: CN-MF-000042263
UDI-DI: 06977568270135
Basic UDI-DI: 697756827002R5
Reference: UT8040S,UT8040-CS
EMDN: W0202059010
EMDN description: TISSUE PROCESSORS
First on market country: -
Authorised representative: MedPath GmbH
Last updated: 16.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

Lumatas Titan S Autostainer

Titan S

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Lumatas BioSystems Inc
Manufacturer SRN: US-MF-000017316
UDI-DI: 00850042030011
Basic UDI-DI: 0850042030TitanSJT
Reference: Lumatas Titan S Autostainer
EMDN: W0202059002
EMDN description: AUTOMATED SLIDE STAINERS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:24

Manufacturer products Authorised representative products Authorised representative actors View details

Lumatas Titan Autostainer

Titan

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Lumatas BioSystems Inc
Manufacturer SRN: US-MF-000017316
UDI-DI: 00850042030004
Basic UDI-DI: 0850042030Titan83
Reference: Lumatas Titan Autostainer
EMDN: W0202059002
EMDN description: AUTOMATED SLIDE STAINERS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:24

Manufacturer products Authorised representative products Authorised representative actors View details

B-Print C

Printers for cassettes or slides

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Bio-Optica Milano S.p.A.
Manufacturer SRN: IT-MF-000027525
UDI-DI: 08055672950193
Basic UDI-DI: 080556729W0202059017KM
Reference: TB686
EMDN: W0202059017
EMDN description: CASSETTE / SLIDE PRINTERS
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 03:32

Manufacturer products View details

BPRO-450

Instruments for histopathology

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Bio-Optica Milano S.p.A.
Manufacturer SRN: IT-MF-000027525
UDI-DI: 08034120278584
Basic UDI-DI: 080341202W0202059010M2
Reference: 40-100-200
EMDN: W0202059010
EMDN description: TISSUE PROCESSORS
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 03:31

Manufacturer products View details

BCP170

Cooling Plate

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Bio-Optica Milano S.p.A.
Manufacturer SRN: IT-MF-000027525
UDI-DI: 08034120274722
Basic UDI-DI: 080341202W0202059012M6
Reference: 40-300-202
EMDN: W0202059012
EMDN description: COOLING PARAFFIN PLATES
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 03:31

Manufacturer products View details

BEC150

Paraffin dispenser

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Bio-Optica Milano S.p.A.
Manufacturer SRN: IT-MF-000027525
UDI-DI: 08034120274715
Basic UDI-DI: 080341202W0202059004M7
Reference: 40-200-002
EMDN: W0202059004
EMDN description: TISSUE EMBEDDING PROCESSORS
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 03:31

Manufacturer products View details

AUS240

Automatic stainer for histocytology

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Bio-Optica Milano S.p.A.
Manufacturer SRN: IT-MF-000027525
UDI-DI: 08034120274685
Basic UDI-DI: 080341202W0202059002M3
Reference: 40-400-350
EMDN: W0202059002
EMDN description: AUTOMATED SLIDE STAINERS
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 03:31

Manufacturer products View details

CVR909

Automatic coverslipper

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Bio-Optica Milano S.p.A.
Manufacturer SRN: IT-MF-000027525
UDI-DI: 08034120272421
Basic UDI-DI: 080341202W0202059008MF
Reference: 40-500-000
EMDN: W0202059008
EMDN description: AUTOMATED COVERSLIPPERS
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 03:31

Manufacturer products View details

TMB - Microtome Bench

Instrument for histology and cytology

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Bio-Optica Milano S.p.A.
Manufacturer SRN: IT-MF-000027525
UDI-DI: 08034120271554
Basic UDI-DI: 080341202W0202059099NC
Reference: 40-300-400
EMDN: W0202059099
EMDN description: VARIOUS PROCESSING INSTRUMENTS FOR HYSTOLOGY / CYTOLOGY - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 03:31

Manufacturer products View details

Trimming Tech 90

Aspirate hood for histology

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Bio-Optica Milano S.p.A.
Manufacturer SRN: IT-MF-000027525
UDI-DI: 08034120270779
Basic UDI-DI: 080341202W0202059015MC
Reference: 50-090-001
EMDN: W0202059015
EMDN description: CUTTING STATION FOR HISTOLOGICAL SAMPLES
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 03:31

Manufacturer products View details

Microtome Knife

Blades and Knives

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: Richard-Allan Scientific LLC
Manufacturer SRN: US-MF-000008261
UDI-DI: 00673693063500
Basic UDI-DI: 0673693RAS017RN
Reference: 152020
EMDN: W0202059085
EMDN description: VARIOUS PROCESSING INSTRUMENTS FOR HYSTOLOGY / CYTOLOGY - CONSUMABLES
First on market country: Netherlands
Authorised representative: Epredia Netherlands B.V.
Last updated: 16.07.2026 01:08

Manufacturer products Authorised representative products Authorised representative actors View details