EUDAMED device

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

EUDAMED device 00615233011312 · Sakura Finetek USA, Inc

Key facts

Primary DI 00615233011312
Trade name Tissue-Tek Genie® anti-Epithelial Cell Adhesion Molecule Mouse Monoclonal Antibody [BS14]
Device name Tissue-Tek Genie® anti-Epithelial Cell Adhesion Molecule Mouse Monoclonal Antibody [BS14]
Reference or catalog number 8337-M250
Model Tissue-Tek Genie® anti-Epithelial Cell Adhesion Molecule Mouse Monoclonal Antibody [BS14]
Manufacturer Sakura Finetek USA, Inc
Manufacturer SRN US-MF-000022208
Risk class Class C
EMDN code W0102039099
EMDN description TUMOUR MARKERS - OTHER
Legislation ivdr
Implantable No
Sterile No
Single use No
Status date Jan 14, 2026

At a glance

  • Yes Matching FDA GUDID record

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About EUDAMED devices

EUDAMED is the European Union's database of medical devices registered under the MDR and IVDR, including UDI-DIs, risk classes and EMDN nomenclature codes.

Source: European Commission, European Database on Medical Devices (EUDAMED) · Source date:

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