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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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Tissue-Tek Genie® PRO Detection Kit, DAB; RTU, cartridge containing 250 test, 1 each, Protein Block, Peroxidase Block, Link, Polymer HRP-Conjugate, DAB, DAB Intensifier/kit

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IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233002662
Basic UDI-DI: 06152338225J8
Reference: 8826-K250
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: -
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 22.09.2026 05:52

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie® DUO Mouse-DAB/Rabbit-AP Red Dual Detection Kit; RTU, cartridge containing 250 tests, 1 each, Protein Block, Link 1, Link 2, Poly HRP + AP Conjugates, DAB , AP Red/kit

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IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233007636
Basic UDI-DI: 06152338225J8
Reference: 8837-K250
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: -
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 22.09.2026 05:52

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie® High pH Antigen Retrieval Solution; RTU, 1 bottle, 3.8 Liters

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IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233002464
Basic UDI-DI: 06152338224J6
Reference: 8744-G001
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: -
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 22.09.2026 05:51

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie® Dewax Solution; RTU, 1 bottle, 3.8 Liters

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IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233002525
Basic UDI-DI: 06152338224J6
Reference: 8865-G001
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: -
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 22.09.2026 05:51

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie® PRO Antibody Diluent; RTU, 4 bottles, 100 mL each/case

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IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233009944
Basic UDI-DI: 06152338224J6
Reference: 8866-G004
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: -
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 22.09.2026 05:51

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie® Wash Buffer Solution; RTU, 4 bottles, 3.8 Liters each/case

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IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233002686
Basic UDI-DI: 06152338224J6
Reference: 8874-G004
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: -
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 22.09.2026 05:51

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie® CISH Amplifier RTU, 100 tests, 1 cartridge; 1 unit

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IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233010216
Basic UDI-DI: 06152338224J6
Reference: 9808-M100
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: -
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 22.09.2026 05:51

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie® SSC Stringent Wash Buffer; RTU, 1 bottle, 3.8L

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IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233010193
Basic UDI-DI: 06152338224J6
Reference: 9810-G001
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: -
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 22.09.2026 05:51

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie® Proteinase K RTU, 100 tests, 1 cartridge; 1 unit

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IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233010209
Basic UDI-DI: 06152338224J6
Reference: 9811-M100
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: -
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 22.09.2026 05:51

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie® Citrate Antigen Retrieval Solution; RTU, 1 bottle, 3.8 Liters

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IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233002457
Basic UDI-DI: 06152338224J6
Reference: 8742-G001
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: -
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 22.09.2026 05:51

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie® anti-SATB2 Rabbit Monoclonal Antibody [QR023]; RTU, 10 capsules, 1 pack.

Tissue-Tek Genie® anti-SATB2 Rabbit Monoclonal Antibody [QR023]

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233011350
Basic UDI-DI: 06152338291JM
Reference: 8356-C010
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 22.09.2026 05:50

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie® anti-Cadherin 17 Rabbit Monoclonal Antibody [QR098]; RTU, 10 capsules, 1 pack.

Tissue-Tek Genie® anti-Cadherin 17 Rabbit Monoclonal Antibody [QR098] RTU, 10 capsules; 1 pack

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233013965
Basic UDI-DI: 06152338300HV
Reference: 8364-C010
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 22.09.2026 05:50

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie® anti-Epithelial Cell Adhesion Molecule Mouse Monoclonal Antibody [BS14]

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IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233011329
Basic UDI-DI: 06152338304J5
Reference: 8337-C010
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: -
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 22.09.2026 05:49

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie® anti-GATA3 Rabbit Monoclonal Antibody [QR018]; RTU, 10 capsules, 1 pack

Tissue-Tek Genie® anti-GATA3 Rabbit Monoclonal Antibody [QR018]

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233011428
Basic UDI-DI: 06152338298K3
Reference: 8357-C010
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 22.09.2026 05:46

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Abbott Ireland Diagnostics Division
Manufacturer SRN: IE-MF-000010070
UDI-DI: 00380740136710
Basic UDI-DI: 038074AIP0836LJ
Reference: 08P3640
EMDN: W0102152208
EMDN description: STANDARDS AND CALIBRATORS FOR INDIVIDUAL AND SPECIFIC HORMONES /PROTEINS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 05:44

Manufacturer products View details

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IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Abbott Ireland Diagnostics Division
Manufacturer SRN: IE-MF-000010070
UDI-DI: 00380740144876
Basic UDI-DI: 038074ARK0764NG
Reference: 07K6432
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 05:44

Manufacturer products View details

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IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Abbott Ireland, Diagnostics Division
Manufacturer SRN: IE-MF-000009849
UDI-DI: 00380740150570
Basic UDI-DI: 038074AIP0934LK
Reference: 09P3401
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 05:44

Manufacturer products View details

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IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Abbott Ireland Diagnostics Division
Manufacturer SRN: IE-MF-000010070
UDI-DI: 00380740144845
Basic UDI-DI: 038074ARK0764NG
Reference: 07K6402
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 05:44

Manufacturer products View details

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IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Abbott Ireland Diagnostics Division
Manufacturer SRN: IE-MF-000010070
UDI-DI: 00380740144883
Basic UDI-DI: 038074ARK0764NG
Reference: 07K6437
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 05:44

Manufacturer products View details

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IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Abbott Ireland, Diagnostics Division
Manufacturer SRN: IE-MF-000009849
UDI-DI: 00380740150969
Basic UDI-DI: 038074AIP0939LV
Reference: 09P3901
EMDN: W0102080601
EMDN description: CYCLOSPORINE TOTAL
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 05:44

Manufacturer products View details