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EUDAMED Device Search

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

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Antigen Retrieval Buffers

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Diagnostic BioSystems
Manufacturer SRN: US-MF-000028606
UDI-DI: 00846405012435
Basic UDI-DI: 08464050K046CV
Reference: K046
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 13.10.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

Montage™ Hematoxylin

Histological Stains

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Diagnostic BioSystems
Manufacturer SRN: US-MF-000028606
UDI-DI: 00846405012411
Basic UDI-DI: 08464050K056100ANN2
Reference: K056-100AN
EMDN: W01030708
EMDN description: STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 13.10.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue Sealants

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Diagnostic BioSystems
Manufacturer SRN: US-MF-000028606
UDI-DI: 00846405012404
Basic UDI-DI: 08464050K024CK
Reference: K024
EMDN: W01030706
EMDN description: MOUNTING MEDIA (HISTOLOGY/CYTOLOGY)
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 13.10.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

Fluoromount/Plus™

Tissue Sealants

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Diagnostic BioSystems
Manufacturer SRN: US-MF-000028606
UDI-DI: 00846405012381
Basic UDI-DI: 08464050K048CZ
Reference: K048
EMDN: W01030706
EMDN description: MOUNTING MEDIA (HISTOLOGY/CYTOLOGY)
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 13.10.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

General Purpose Reagents

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Diagnostic BioSystems
Manufacturer SRN: US-MF-000028606
UDI-DI: 00846405012367
Basic UDI-DI: 08464050K039CY
Reference: K039
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 13.10.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue Sealants

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Diagnostic BioSystems
Manufacturer SRN: US-MF-000028606
UDI-DI: 00846405012343
Basic UDI-DI: 08464050K002C9
Reference: K002
EMDN: W01030706
EMDN description: MOUNTING MEDIA (HISTOLOGY/CYTOLOGY)
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 13.10.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

Montage DAB Gone kit

General Purpose Reagents

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Diagnostic BioSystems
Manufacturer SRN: US-MF-000028606
UDI-DI: 00846405012350
Basic UDI-DI: 08464050K072500ANNU
Reference: K072-500AN
EMDN: W01030711
EMDN description: IMMUNOHISTOLOGY KITS
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 13.10.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

Broad Spectrum Negative Control

General Purpose Reagents

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Diagnostic BioSystems
Manufacturer SRN: US-MF-000028606
UDI-DI: 00846405012329
Basic UDI-DI: 08464050K05306UC
Reference: K053
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 13.10.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

Background Blocker

Blocking Reagents

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Diagnostic BioSystems
Manufacturer SRN: US-MF-000028606
UDI-DI: 00846405012299
Basic UDI-DI: 08464050K023CH
Reference: K023IVDD
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 13.10.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

Alkaline Phosphatase Enhancer

General Purpose Reagents

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Diagnostic BioSystems
Manufacturer SRN: US-MF-000028606
UDI-DI: 00846405012282
Basic UDI-DI: 08464050K011CA
Reference: K011
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 13.10.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

40X Immuno Wash Buffer

Antigen Retrieval Buffers

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Diagnostic BioSystems
Manufacturer SRN: US-MF-000028606
UDI-DI: 00846405012275
Basic UDI-DI: 08464050K080CV
Reference: K080
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 13.10.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

10X Tris-EDTA Buffer for Heat Induced Epitope Recovery, pH 9.0

Antigen Retrieval Buffers

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Diagnostic BioSystems
Manufacturer SRN: US-MF-000028606
UDI-DI: 00846405012268
Basic UDI-DI: 08464050K043CP
Reference: K043
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 13.10.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

10X EDTA Buffer for Heat Induced Epitope Recovery, pH 8.0

Antigen Retrieval Buffers

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Diagnostic BioSystems
Manufacturer SRN: US-MF-000028606
UDI-DI: 00846405012251
Basic UDI-DI: 08464050K038CW
Reference: K038
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 13.10.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

10X Citrate Buffer for Heat Induced Epitope Recovery, pH 8.0

Antigen Retrieval Buffers

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Diagnostic BioSystems
Manufacturer SRN: US-MF-000028606
UDI-DI: 00846405012244
Basic UDI-DI: 08464050K037CU
Reference: K037
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 13.10.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

10X Citrate Buffer for Heat Induced Epitope Recovery, pH 7.0

Antigen Retrieval Buffers

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Diagnostic BioSystems
Manufacturer SRN: US-MF-000028606
UDI-DI: 00846405012237
Basic UDI-DI: 08464050K036CS
Reference: K036
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 13.10.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

10X Citrate Buffer for Heat Induced Epitope Recovery, pH 6.0

Antigen Retrieval Buffers

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Diagnostic BioSystems
Manufacturer SRN: US-MF-000028606
UDI-DI: 00846405012220
Basic UDI-DI: 08464050K035CQ
Reference: K035
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 13.10.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

10X Antigen Retrieval Buffer High pH 10.0

Antigen Retrieval Buffers

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Diagnostic BioSystems
Manufacturer SRN: US-MF-000028606
UDI-DI: 00846405012213
Basic UDI-DI: 08464050K044CR
Reference: K044
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 13.10.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

CD61 Platelet Glycoprotein Illa

Primary Antibodies

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Diagnostic BioSystems
Manufacturer SRN: US-MF-000028606
UDI-DI: 00846405005642
Basic UDI-DI: B-00846405005642
Reference: Mob164-01
EMDN: W0102010113
EMDN description: HUMAN ANTI-MOUSE ANTIBODY
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 13.10.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

CD61 Platelet Glycoprotein Illa

Primary Antibodies

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Diagnostic BioSystems
Manufacturer SRN: US-MF-000028606
UDI-DI: 00846405005635
Basic UDI-DI: B-00846405005635
Reference: Mob164-05
EMDN: W0102010113
EMDN description: HUMAN ANTI-MOUSE ANTIBODY
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 13.10.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

CD61 Platelet Glycoprotein Illa

Primary Antibodies

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Diagnostic BioSystems
Manufacturer SRN: US-MF-000028606
UDI-DI: 00846405005628
Basic UDI-DI: B-00846405005628
Reference: Mob164
EMDN: W0102010113
EMDN description: HUMAN ANTI-MOUSE ANTIBODY
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 13.10.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details