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

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307 device results listed.

Page 13 / 16

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Bond Open Container 7 mL

OP79193

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 05055331305114
Basic UDI-DI: 50553313OP791900005SW
Reference: OP79193
EMDN: W02079085
EMDN description: VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - CONSUMABLES
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 31.07.2026 08:15

Manufacturer products Authorised representative products Authorised representative actors View details

BOND Titration Container 6 mL

OPT9049

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 05055331305107
Basic UDI-DI: 50553313OPT90400005CK
Reference: OPT9049
EMDN: W02079085
EMDN description: VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - CONSUMABLES
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 31.07.2026 08:14

Manufacturer products Authorised representative products Authorised representative actors View details

BOND Titration Container Inserts 50 Pack

OPT9719

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 05055331305091
Basic UDI-DI: 50553313OPT97100005F3
Reference: OPT9719
EMDN: W02079085
EMDN description: VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - CONSUMABLES
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 31.07.2026 08:14

Manufacturer products Authorised representative products Authorised representative actors View details

Epithelial Membrane Antigen GP1.4 7 mL

PA0035

IVD Class CIVDR 2017/746On the marketDirect marking

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 05055331304704
Basic UDI-DI: 50553313EMAGP1000029A
Reference: PA0035
EMDN: W01030709
EMDN description: PRIMARY ANTISERA FOR IMMUNOHISTOLOGY
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 31.07.2026 08:14

Manufacturer products Authorised representative products Authorised representative actors View details

Negative (Rabbit) 7mL

PA0777

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 05055331303837
Basic UDI-DI: 50553313NEGRAB00002L5
Reference: PA0777
EMDN: W01030709
EMDN description: PRIMARY ANTISERA FOR IMMUNOHISTOLOGY
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 31.07.2026 08:14

Manufacturer products Authorised representative products Authorised representative actors View details

Negative (Rabbit) 7mL

PA0996

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 05055331303707
Basic UDI-DI: 50553313NEGMOU00002YB
Reference: PA0996
EMDN: W01030709
EMDN description: PRIMARY ANTISERA FOR IMMUNOHISTOLOGY
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 31.07.2026 08:14

Manufacturer products Authorised representative products Authorised representative actors View details

Novocastra Peroxidase Block

RE7101

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 05055331302137
Basic UDI-DI: 50553313PERBLO00004XQ
Reference: RE7101
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 31.07.2026 08:14

Manufacturer products Authorised representative products Authorised representative actors View details

Novocastra Protein Block

RE7102

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 05055331302120
Basic UDI-DI: 50553313PROBLO000049F
Reference: RE7102
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 31.07.2026 08:14

Manufacturer products Authorised representative products Authorised representative actors View details

Novocastra Streptavidin-HRP

RE7104

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingMicrobial substancesProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 05055331302106
Basic UDI-DI: 50553313STRHRP00004PG
Reference: RE7104
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 31.07.2026 08:14

Manufacturer products Authorised representative products Authorised representative actors View details

Novocastra Hematoxylin

RE7107

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 05055331302090
Basic UDI-DI: 50553313HEMATO00004Q2
Reference: RE7107
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 31.07.2026 08:14

Manufacturer products Authorised representative products Authorised representative actors View details

Novocastra Peroxidase Detection System (250 tests)

RE7110-K

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 05055331302083
Basic UDI-DI: 50553313PERDET00004X8
Reference: RE7110-K
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 31.07.2026 08:14

Manufacturer products Authorised representative products Authorised representative actors View details

Epitope Retrieval Solution (x10 Concentrate) pH6

RE7113

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 05055331302076
Basic UDI-DI: 50553313MERPH600004R9
Reference: RE7113
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 31.07.2026 08:14

Manufacturer products Authorised representative products Authorised representative actors View details

Epitope Retrieval Solution (x10 Concentrate) pH8

RE7116

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 05055331302052
Basic UDI-DI: 50553313MERPH800004S3
Reference: RE7116
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 31.07.2026 08:14

Manufacturer products Authorised representative products Authorised representative actors View details

Epitope Retrieval Solution (x10 Concentrate) pH9

RE7119

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 05055331302045
Basic UDI-DI: 50553313MERPH900004SG
Reference: RE7119
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 31.07.2026 08:14

Manufacturer products Authorised representative products Authorised representative actors View details

Novocastra IHC Diluent

RE7133

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 05055331302007
Basic UDI-DI: 50553313MIHCDI00004K6
Reference: RE7133
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 31.07.2026 08:14

Manufacturer products Authorised representative products Authorised representative actors View details

Novocastra Enzyme Proteinase K (IHC)

RE7160-K

IVD Class AIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 05055331301970
Basic UDI-DI: 50553313ENPROK000045C
Reference: RE7160-K
EMDN: W01030709
EMDN description: PRIMARY ANTISERA FOR IMMUNOHISTOLOGY
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 31.07.2026 08:14

Manufacturer products Authorised representative products Authorised representative actors View details

Novolink Max Polymer (1250 tests)

RE7200-K

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 05055331301895
Basic UDI-DI: 50553313NOVPOL00004JH
Reference: RE7260-K
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 31.07.2026 08:14

Manufacturer products Authorised representative products Authorised representative actors View details

MAX DAB (Polymer) 1250 tests)

RE7230-K

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 05055331301888
Basic UDI-DI: 50553313NOVDAB00004XS
Reference: RE7270-K
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 31.07.2026 08:14

Manufacturer products Authorised representative products Authorised representative actors View details

Novolink Min Polymer Detection System (50 tests)

RE7140-K

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 05055331301864
Basic UDI-DI: 50553313NVPLDT00004FK
Reference: RE7290-K
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 31.07.2026 08:14

Manufacturer products Authorised representative products Authorised representative actors View details

Anaplastic Lymphoma Kinase 5A4 7 mL

PA0831

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 05055331328700
Basic UDI-DI: B-05055331328700
Reference: PA0831
EMDN: W01030709
EMDN description: PRIMARY ANTISERA FOR IMMUNOHISTOLOGY
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 23.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors View details