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

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Active filter:Manufacturer SRN:CN-MF-000036196

20 device results listed.

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High Risk Human Papillomavirus (HPV) Genotyping System

IVD generalIVDDNo longer on the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Dalton BioSciences, Ltd.
Manufacturer SRN: CN-MF-000036196
UDI-DI: 06973873149074
Basic UDI-DI: B-06973873149074
Reference: HPVS02
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Portugal
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 17:43

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic immunocytochemical staining machine

HB-100H

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Dalton BioSciences, Ltd.
Manufacturer SRN: CN-MF-000036196
UDI-DI: 06973873149067
Basic UDI-DI: 697387314HBHU2
Reference: HB-100H
EMDN: W0202059002
EMDN description: AUTOMATED SLIDE STAINERS
First on market country: -
Authorised representative: Humiss Beratung GmbH
Last updated: 02.07.2026 15:08

Manufacturer products Authorised representative products Authorised representative actors View details

Liquid-Based Cytology Slide Processor

ZP-2A

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Dalton BioSciences, Ltd.
Manufacturer SRN: CN-MF-000036196
UDI-DI: 06973873149050
Basic UDI-DI: 697387314ZPAXQ
Reference: ZP-2A
EMDN: W0202059099
EMDN description: VARIOUS PROCESSING INSTRUMENTS FOR HYSTOLOGY / CYTOLOGY - OTHER
First on market country: -
Authorised representative: Humiss Beratung GmbH
Last updated: 02.07.2026 15:08

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Hybrid Capture System

HB-104C

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Dalton BioSciences, Ltd.
Manufacturer SRN: CN-MF-000036196
UDI-DI: 06973873149029
Basic UDI-DI: 697387314HBCTQ
Reference: HB-104C
EMDN: W0201020104
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput > 700 test/h)
First on market country: -
Authorised representative: Humiss Beratung GmbH
Last updated: 02.07.2026 15:08

Manufacturer products Authorised representative products Authorised representative actors View details

Chemiluminescence Immunoassay Analyzer

CS-SA301C

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Dalton BioSciences, Ltd.
Manufacturer SRN: CN-MF-000036196
UDI-DI: 06973873149012
Basic UDI-DI: 697387314SACVC
Reference: CS-SA301C
EMDN: W0201020104
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput > 700 test/h)
First on market country: -
Authorised representative: Humiss Beratung GmbH
Last updated: 02.07.2026 15:08

Manufacturer products Authorised representative products Authorised representative actors View details

Wash Buffer

WB3-50

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingProfessional testingSingle use

Manufacturer: Hangzhou Dalton BioSciences, Ltd.
Manufacturer SRN: CN-MF-000036196
UDI-DI: 06973873141092
Basic UDI-DI: 697387314WB3V5
Reference: WB3-50
EMDN: W0104010805
EMDN description: BUFFERS
First on market country: -
Authorised representative: Humiss Beratung GmbH
Last updated: 02.07.2026 15:08

Manufacturer products Authorised representative products Authorised representative actors View details

06973873141061

AR3-2.5

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingProfessional testingReagentSingle use

Manufacturer: Hangzhou Dalton BioSciences, Ltd.
Manufacturer SRN: CN-MF-000036196
UDI-DI: 06973873141061
Basic UDI-DI: 697387314ARBU3
Reference: AR3-2.5
EMDN: W01040404
EMDN description: OTHER TISSUE CULTURE ADDITIVES AND SOLUTIONS
First on market country: -
Authorised representative: Humiss Beratung GmbH
Last updated: 02.07.2026 15:08

Manufacturer products Authorised representative products Authorised representative actors View details

Cell Preservation Solution

CPS-025-10

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingProfessional testingReagentSingle use

Manufacturer: Hangzhou Dalton BioSciences, Ltd.
Manufacturer SRN: CN-MF-000036196
UDI-DI: 06973873141047
Basic UDI-DI: 697387314CPSV9
Reference: CPS-025-10
EMDN: W01040404
EMDN description: OTHER TISSUE CULTURE ADDITIVES AND SOLUTIONS
First on market country: -
Authorised representative: Humiss Beratung GmbH
Last updated: 02.07.2026 15:08

Manufacturer products Authorised representative products Authorised representative actors View details

Specimen Preservation Solution

Human Papillomavirus (HPV) Nucleic Acid Detection Kit (Hybrid Capture-CLIA)

IVD Class CIVDR 2017/746Not intended for EU marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Dalton BioSciences, Ltd.
Manufacturer SRN: CN-MF-000036196
UDI-DI: 06973873141023
Basic UDI-DI: 697387314DH3SQ
Reference: SPS-045
EMDN: W01040404
EMDN description: OTHER TISSUE CULTURE ADDITIVES AND SOLUTIONS
First on market country: -
Authorised representative: MedPath GmbH
Last updated: 30.06.2026 12:09

Manufacturer products Authorised representative products Authorised representative actors View details

Human Papillomavirus (HPV) Nucleic Acid Detection Kit (Hybrid Capture-CLIA)

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Dalton BioSciences, Ltd.
Manufacturer SRN: CN-MF-000036196
UDI-DI: 06973873140118
Basic UDI-DI: 697387314DH3SQ
Reference: DH3-192
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 30.06.2026 12:09

Manufacturer products Authorised representative products Authorised representative actors View details

Human Papillomavirus (HPV) Nucleic Acid Detection Kit (Hybrid Capture-CLIA)

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Dalton BioSciences, Ltd.
Manufacturer SRN: CN-MF-000036196
UDI-DI: 06973873140101
Basic UDI-DI: 697387314DH3SQ
Reference: DH3-072
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 30.06.2026 12:09

Manufacturer products Authorised representative products Authorised representative actors View details

Human Papillomavirus (HPV) Nucleic Acid Detection Kit (Hybrid Capture-CLIA)

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Dalton BioSciences, Ltd.
Manufacturer SRN: CN-MF-000036196
UDI-DI: 06973873140026
Basic UDI-DI: 697387314DH3SQ
Reference: DH3-096
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 30.06.2026 12:09

Manufacturer products Authorised representative products Authorised representative actors View details

Human Papillomavirus (HPV) Nucleic Acid Detection Kit (Hybrid Capture-CLIA)

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Dalton BioSciences, Ltd.
Manufacturer SRN: CN-MF-000036196
UDI-DI: 06973873140019
Basic UDI-DI: 697387314DH3SQ
Reference: DH3-048
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 30.06.2026 12:09

Manufacturer products Authorised representative products Authorised representative actors View details

Cell Preservation Solution

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingProfessional testingReagentSingle use

Manufacturer: Hangzhou Dalton BioSciences, Ltd.
Manufacturer SRN: CN-MF-000036196
UDI-DI: 06973873141054
Basic UDI-DI: 697387314CPSV9
Reference: CPS-025-20
EMDN: W01040404
EMDN description: OTHER TISSUE CULTURE ADDITIVES AND SOLUTIONS
First on market country: -
Authorised representative: Humiss Beratung GmbH
Last updated: 16.06.2026 13:12

Manufacturer products Authorised representative products Authorised representative actors View details

Antigen Retrieval Buffer

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingProfessional testingReagentSingle use

Manufacturer: Hangzhou Dalton BioSciences, Ltd.
Manufacturer SRN: CN-MF-000036196
UDI-DI: 06973873141078
Basic UDI-DI: 697387314ARBU3
Reference: AR3-100
EMDN: W01040404
EMDN description: OTHER TISSUE CULTURE ADDITIVES AND SOLUTIONS
First on market country: -
Authorised representative: Humiss Beratung GmbH
Last updated: 16.06.2026 13:12

Manufacturer products Authorised representative products Authorised representative actors View details

Antigen Retrieval Buffer

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingProfessional testingReagentSingle use

Manufacturer: Hangzhou Dalton BioSciences, Ltd.
Manufacturer SRN: CN-MF-000036196
UDI-DI: 06973873141085
Basic UDI-DI: 697387314ARBU3
Reference: AR3-5000
EMDN: W01040404
EMDN description: OTHER TISSUE CULTURE ADDITIVES AND SOLUTIONS
First on market country: -
Authorised representative: Humiss Beratung GmbH
Last updated: 16.06.2026 13:12

Manufacturer products Authorised representative products Authorised representative actors View details

Wash Buffer

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingProfessional testingSingle use

Manufacturer: Hangzhou Dalton BioSciences, Ltd.
Manufacturer SRN: CN-MF-000036196
UDI-DI: 06973873141108
Basic UDI-DI: 697387314WB3V5
Reference: WB3-150
EMDN: W0104010805
EMDN description: BUFFERS
First on market country: -
Authorised representative: Humiss Beratung GmbH
Last updated: 16.06.2026 13:12

Manufacturer products Authorised representative products Authorised representative actors View details

Wash Buffer

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingProfessional testingSingle use

Manufacturer: Hangzhou Dalton BioSciences, Ltd.
Manufacturer SRN: CN-MF-000036196
UDI-DI: 06973873141115
Basic UDI-DI: 697387314WB3V5
Reference: WB3-5000
EMDN: W0104010805
EMDN description: BUFFERS
First on market country: -
Authorised representative: Humiss Beratung GmbH
Last updated: 16.06.2026 13:12

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Hybrid Capture System

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Dalton BioSciences, Ltd.
Manufacturer SRN: CN-MF-000036196
UDI-DI: 06973873149036
Basic UDI-DI: 697387314HBCTQ
Reference: HB-304C
EMDN: W0201020104
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput > 700 test/h)
First on market country: -
Authorised representative: Humiss Beratung GmbH
Last updated: 16.06.2026 13:12

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Hybrid Capture System

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Dalton BioSciences, Ltd.
Manufacturer SRN: CN-MF-000036196
UDI-DI: 06973873149043
Basic UDI-DI: 697387314HBCTQ
Reference: HB-314C
EMDN: W0201020104
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput > 700 test/h)
First on market country: -
Authorised representative: Humiss Beratung GmbH
Last updated: 16.06.2026 13:12

Manufacturer products Authorised representative products Authorised representative actors View details