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Sakura Finetek USA, Inc

United States·US-MF-000022208

Last updated June 8, 2026

Information

Country: United States
Address: 1750, West 214th Street, Torrance, CA, United States
Website: sakuraus.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Solmaz Shaida
EUDAMED SRN: US-MF-000022208
FDA FEI Number: —
DUNS Number: —

Catalogue (921)

Page 19 of 19

Device	Model / Reference	Registries	Class	Status
Tissue-Tek Genie® anti-TRPS1 Rabbit Polyclonal Antibody [ZR382]	8359-C010	EUDAMED	Class C	Active
Tissue-Tek Genie® anti-MUC2 Mouse Monoclonal Antibody [CCP58]	8305-C010	EUDAMEDFDA UDI	Class C	Active
Tissue-Tek Genie® anti-OCT3/4 Mouse Monoclonal Antibody [C-10]	8288-C010	EUDAMED	Class C	Active
Tissue-Tek Genie® anti-INSM1 Rabbit Monoclonal Antibody [ZR395]	8379-M250	EUDAMED	Class C	Active
Tissue-Tek Genie®	8344-M250	EUDAMEDFDA UDI	Class C	Active
Sakura-Medscand Sca-1800 Automatic Coverslipper	K882881	FDA 510(k)	Class I	Active
Sakura Hem-480 Electron Microscopy Processor	K881165	FDA 510(k)	Class I	Active
Sakura Prep Ai Automatic Liquid Handling System	K893811	FDA 510(k)	Class I	Active
Sakura Drs-60 Automatic Slide Stainer	K874897	FDA 510(k)	Class I	Active
Tissue-Tek Genie®	8388-M250	EUDAMEDFDA UDI	Class C	Active
Tissue-Tek Genie®	8280-C010	EUDAMEDFDA UDI	Class C	Active
Tissue-Tek Genie® anti-MUC5AC Mouse Monoclonal Antibody [Nd-2]	8299-C010	EUDAMEDFDA UDI	Class C	Active
Tissue-Tek Genie®	8364-C010	EUDAMEDFDA UDI	Class C	Active
Tissue-Tek Genie® anti-Epithelial Cell Adhesion Molecule Mouse Monoclonal Antibody [BS14]	8337-M250	EUDAMEDFDA UDI	Class C	Active
Tissue-Tek Genie® anti-SALL4 Mouse Monoclonal Antibody [6E3]	8358-C010	EUDAMED	Class C	Active
Tissue-Tek Genie®	8357-C010	EUDAMEDFDA UDI	Class C	Active
Tissue-Tek Genie® anti-INSM1 Rabbit Monoclonal Antibody [ZR395]	8379-C010	EUDAMED	Class C	Active
Tissue-Tek Genie® anti-TRPS1 Rabbit Polyclonal Antibody [ZR382]	8359-M250	EUDAMED	Class C	Active
Tissue-Tek Genie® anti-Epithelial Cell Adhesion Molecule Mouse Monoclonal Antibody [BS14]	8337-C010	EUDAMEDFDA UDI	Class C	Active
Tissue-Tek Genie®	8276-C010	EUDAMEDFDA UDI	Class C	Active
Tissue-Tek Genie®	8344-C010	EUDAMEDFDA UDI	Class C	Active

Related Companies

Authorised Representatives

Sakura Finetek Europe B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Apr 16, 2014	Z-1748-2014	—	terminated	This Lot has variations in melting temperature.