MD Atlas update: Aug 28, 2026

Sakura Finetek USA, Inc

US-MF-000022208

Active83 devices

Address: West 214th Street, 1750 90501 Torrance, CA
Role: Manufacturer
Date of registration: Mar 30, 2022
Country: United States

Sakura Finetek USA, Inc is a medical device manufacturer registered in EUDAMED. The company has 83 devices on the EU market across 32 countries. Headquartered in Torrance, CA, United States. Explore the regulatory profile, devices and certificates on MD Atlas.

About Sakura Finetek USA, Inc

: US-MF-000022208
Role: Manufacturer
Country: United States
Organization name: Sakura Finetek USA, Inc
EU VAT number: Not applicable
Date of registration: Mar 30, 2022

Contact details for Sakura Finetek USA, Inc

Email: PRRC@sakuraus.com
Address: 1750, WEST 214TH STREET 90501 TORRANCE, CA UNITED STATES

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Competent authority

Name: Ministerie van Volksgezondheid, Welzijn en Sport

Phone: +31 70 340 79 11
Email: medische_hulpmiddelen@minvws.nl

Officers and regulatory representatives of Sakura Finetek USA, Inc

SHAIDA Solmaz
Hidden

Connected operators

Importers

1 EU importer places this manufacturer's devices

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
Cryomold® Biopsy 10 x 10 x 5 mm, 100/cs	Cryomold® Biopsy 10 x 10 x 5 mm, 100/cs	`4565`	`10615233078633`	1200	On the market
Cryomold® Intermediate 15 x 15 x 5 mm, 100/cs	Cryomold® Intermediate 15 x 15 x 5 mm, 100/cs	`4566`	`10615233078640`	1200	On the market
Cryomold® Standard 25 x 20 x 5 mm, 100/cs	Cryomold® Standard 25 x 20 x 5 mm, 100/cs	`4557`	`10615233078626`	1200	On the market
Round Cryomold® Biopsy 15mm, 100/cs	Round Cryomold® Biopsy 15mm, 100/cs	`4730`	`10615233078787`	1200	On the market
Round Cryomold® Standard, 23mm, 100/cs	Round Cryomold® Standard, 23mm, 100/cs	`4728`	`10615233078770`	1200	On the market
Tissue-Tek AutoSection®	Tissue-Tek AutoSection®	`5000`	`00615233079329`	1	On the market
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.	`8364-C010`	`00615233013965`	10	On the market
Tissue-Tek Genie® anti-Calretinin Rabbit Polyclonal Antibody	Tissue-Tek Genie® anti-Calretinin Rabbit Polyclonal Antibody	`8223-C010`	`00615233000361`	1	On the market
Tissue-Tek Genie® anti-CD10 Mouse Monoclonal Antibody [GM003]	Tissue-Tek Genie® anti-CD10 Mouse Monoclonal Antibody [GM003]	`8253-C010`	`00615233000644`	1	On the market
Tissue-Tek Genie® anti-CD10 Rabbit Monoclonal Antibody [QR021]; RTU, 10 capsules, 1 pack.	Tissue-Tek Genie® anti-CD10 Rabbit Monoclonal Antibody [QR021]; RTU, 10 capsules, 1 pack.	`8386-C010`	`00615233010605`	10	On the market
Tissue-Tek Genie® anti-CD138 Mouse Monoclonal Antibody [B-A38]	Tissue-Tek Genie® anti-CD138 Mouse Monoclonal Antibody [B-A38]	`8241-C010`	`00615233000484`	1	On the market
Tissue-Tek Genie® anti-CD163 Rabbit Monoclonal Antibody [EP324]	Tissue-Tek Genie® anti-CD163 Rabbit Monoclonal Antibody [EP324]	`8245-C010`	`00615233000538`	1	On the market
Tissue-Tek Genie® anti-CD1a Rabbit Monoclonal Antibody [EP80]	Tissue-Tek Genie® anti-CD1a Rabbit Monoclonal Antibody [EP80]	`8246-C010`	`00615233000569`	1	On the market
Tissue-Tek Genie® anti-CD2 Rabbit Monoclonal Antibody [EP222]	Tissue-Tek Genie® anti-CD2 Rabbit Monoclonal Antibody [EP222]	`8255-C010`	`00615233000651`	1	On the market
Tissue-Tek Genie® anti-CD3 Mouse Monoclonal Antibody [ZM45]; RTU, 10 capsules, 1 pack.	Tissue-Tek Genie® anti-CD3 Mouse Monoclonal Antibody [ZM45]; RTU, 10 capsules, 1 pack.	`8344-C010`	`00615233010391`	10	On the market
Tissue-Tek Genie® anti-CD3 Mouse Monoclonal Antibody [ZM45]; RTU, 250 tests, 1 cartridge.	Tissue-Tek Genie® anti-CD3 Mouse Monoclonal Antibody [ZM45]; RTU, 250 tests, 1 cartridge.	`8344-M250`	`00615233010407`	1	On the market
Tissue-Tek Genie® anti-CD3 Rabbit Monoclonal Antibody [EP177]; RTU, 10 capsules; 1 pack	Tissue-Tek Genie® anti-CD3 Rabbit Monoclonal Antibody [EP177]; RTU, 10 capsules; 1 pack	`8280-C010`	`00615233000996`	10	On the market
Tissue-Tek Genie® anti-CD3 Rabbit Monoclonal Antibody [EP177]; RTU, 250 tests, 1 cartridge; 1 unit	Tissue-Tek Genie® anti-CD3 Rabbit Monoclonal Antibody [EP177]; RTU, 250 tests, 1 cartridge; 1 unit	`8280-M250`	`00615233001009`	1	On the market
Tissue-Tek Genie® anti-CD4 Rabbit Monoclonal Antibody [EP204]	Tissue-Tek Genie® anti-CD4 Rabbit Monoclonal Antibody [EP204]	`8226-C010`	`00615233008459`	1	On the market
Tissue-Tek Genie® anti-CD5 Rabbit Monoclonal Antibody [GR020]	Tissue-Tek Genie® anti-CD5 Rabbit Monoclonal Antibody [GR020]	`8249-C010`	`00615233000576`	1	On the market
Tissue-Tek Genie® anti-CD7 Rabbit Monoclonal Antibody [EP132]	Tissue-Tek Genie® anti-CD7 Rabbit Monoclonal Antibody [EP132]	`8251-C010`	`00615233000606`	1	On the market
Tissue-Tek Genie® anti-CD8 Mouse Monoclonal Antibody [C8/144B]	Tissue-Tek Genie® anti-CD8 Mouse Monoclonal Antibody [C8/144B]	`8252-C010`	`00615233000613`	1	On the market
Tissue-Tek Genie® anti-CEA Mouse Monoclonal Antibody [COL1]	Tissue-Tek Genie® anti-CEA Mouse Monoclonal Antibody [COL1]	`8225-C010`	`00615233008435`	1	On the market
Tissue-Tek Genie® anti-Cytokeratin 8 Rabbit Monoclonal Antibody [EP17]	Tissue-Tek Genie® anti-Cytokeratin 8 Rabbit Monoclonal Antibody [EP17]	`8238-C010`	`00615233000453`	1	On the market
Tissue-Tek Genie® anti-E-Cadherin Mouse Monoclonal Antibody [GM016]	Tissue-Tek Genie® anti-E-Cadherin Mouse Monoclonal Antibody [GM016]	`8229-C010`	`00615233008473`	1	On the market

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
Cryomold® Biopsy 10 x 10 x 5 mm, 100/cs	Cryomold® Biopsy 10 x 10 x 5 mm, 100/cs	`4565`	`10615233078633`	1200	On the market
Cryomold® Intermediate 15 x 15 x 5 mm, 100/cs	Cryomold® Intermediate 15 x 15 x 5 mm, 100/cs	`4566`	`10615233078640`	1200	On the market
Cryomold® Standard 25 x 20 x 5 mm, 100/cs	Cryomold® Standard 25 x 20 x 5 mm, 100/cs	`4557`	`10615233078626`	1200	On the market
Round Cryomold® Biopsy 15mm, 100/cs	Round Cryomold® Biopsy 15mm, 100/cs	`4730`	`10615233078787`	1200	On the market
Round Cryomold® Standard, 23mm, 100/cs	Round Cryomold® Standard, 23mm, 100/cs	`4728`	`10615233078770`	1200	On the market
Tissue-Tek AutoSection®	Tissue-Tek AutoSection®	`5000`	`00615233079329`	1	On the market
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.	`8364-C010`	`00615233013965`	10	On the market
Tissue-Tek Genie® anti-Calretinin Rabbit Polyclonal Antibody	Tissue-Tek Genie® anti-Calretinin Rabbit Polyclonal Antibody	`8223-C010`	`00615233000361`	1	On the market
Tissue-Tek Genie® anti-CD10 Mouse Monoclonal Antibody [GM003]	Tissue-Tek Genie® anti-CD10 Mouse Monoclonal Antibody [GM003]	`8253-C010`	`00615233000644`	1	On the market
Tissue-Tek Genie® anti-CD10 Rabbit Monoclonal Antibody [QR021]; RTU, 10 capsules, 1 pack.	Tissue-Tek Genie® anti-CD10 Rabbit Monoclonal Antibody [QR021]; RTU, 10 capsules, 1 pack.	`8386-C010`	`00615233010605`	10	On the market
Tissue-Tek Genie® anti-CD138 Mouse Monoclonal Antibody [B-A38]	Tissue-Tek Genie® anti-CD138 Mouse Monoclonal Antibody [B-A38]	`8241-C010`	`00615233000484`	1	On the market
Tissue-Tek Genie® anti-CD163 Rabbit Monoclonal Antibody [EP324]	Tissue-Tek Genie® anti-CD163 Rabbit Monoclonal Antibody [EP324]	`8245-C010`	`00615233000538`	1	On the market
Tissue-Tek Genie® anti-CD1a Rabbit Monoclonal Antibody [EP80]	Tissue-Tek Genie® anti-CD1a Rabbit Monoclonal Antibody [EP80]	`8246-C010`	`00615233000569`	1	On the market
Tissue-Tek Genie® anti-CD2 Rabbit Monoclonal Antibody [EP222]	Tissue-Tek Genie® anti-CD2 Rabbit Monoclonal Antibody [EP222]	`8255-C010`	`00615233000651`	1	On the market
Tissue-Tek Genie® anti-CD3 Mouse Monoclonal Antibody [ZM45]; RTU, 10 capsules, 1 pack.	Tissue-Tek Genie® anti-CD3 Mouse Monoclonal Antibody [ZM45]; RTU, 10 capsules, 1 pack.	`8344-C010`	`00615233010391`	10	On the market
Tissue-Tek Genie® anti-CD3 Mouse Monoclonal Antibody [ZM45]; RTU, 250 tests, 1 cartridge.	Tissue-Tek Genie® anti-CD3 Mouse Monoclonal Antibody [ZM45]; RTU, 250 tests, 1 cartridge.	`8344-M250`	`00615233010407`	1	On the market
Tissue-Tek Genie® anti-CD3 Rabbit Monoclonal Antibody [EP177]; RTU, 10 capsules; 1 pack	Tissue-Tek Genie® anti-CD3 Rabbit Monoclonal Antibody [EP177]; RTU, 10 capsules; 1 pack	`8280-C010`	`00615233000996`	10	On the market
Tissue-Tek Genie® anti-CD3 Rabbit Monoclonal Antibody [EP177]; RTU, 250 tests, 1 cartridge; 1 unit	Tissue-Tek Genie® anti-CD3 Rabbit Monoclonal Antibody [EP177]; RTU, 250 tests, 1 cartridge; 1 unit	`8280-M250`	`00615233001009`	1	On the market
Tissue-Tek Genie® anti-CD4 Rabbit Monoclonal Antibody [EP204]	Tissue-Tek Genie® anti-CD4 Rabbit Monoclonal Antibody [EP204]	`8226-C010`	`00615233008459`	1	On the market
Tissue-Tek Genie® anti-CD5 Rabbit Monoclonal Antibody [GR020]	Tissue-Tek Genie® anti-CD5 Rabbit Monoclonal Antibody [GR020]	`8249-C010`	`00615233000576`	1	On the market
Tissue-Tek Genie® anti-CD7 Rabbit Monoclonal Antibody [EP132]	Tissue-Tek Genie® anti-CD7 Rabbit Monoclonal Antibody [EP132]	`8251-C010`	`00615233000606`	1	On the market
Tissue-Tek Genie® anti-CD8 Mouse Monoclonal Antibody [C8/144B]	Tissue-Tek Genie® anti-CD8 Mouse Monoclonal Antibody [C8/144B]	`8252-C010`	`00615233000613`	1	On the market
Tissue-Tek Genie® anti-CEA Mouse Monoclonal Antibody [COL1]	Tissue-Tek Genie® anti-CEA Mouse Monoclonal Antibody [COL1]	`8225-C010`	`00615233008435`	1	On the market
Tissue-Tek Genie® anti-Cytokeratin 8 Rabbit Monoclonal Antibody [EP17]	Tissue-Tek Genie® anti-Cytokeratin 8 Rabbit Monoclonal Antibody [EP17]	`8238-C010`	`00615233000453`	1	On the market
Tissue-Tek Genie® anti-E-Cadherin Mouse Monoclonal Antibody [GM016]	Tissue-Tek Genie® anti-E-Cadherin Mouse Monoclonal Antibody [GM016]	`8229-C010`	`00615233008473`	1	On the market

Sakura Finetek USA, Inc

About Sakura Finetek USA, Inc

Contact details for Sakura Finetek USA, Inc

Export the 83 devices of Sakura Finetek USA, Inc

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Officers and regulatory representatives of Sakura Finetek USA, Inc

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About Sakura Finetek USA, Inc

Contact details for Sakura Finetek USA, Inc

Export the 83 devices of Sakura Finetek USA, Inc

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Device catalog for Sakura Finetek USA, Inc

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Importers

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Certificate health for Sakura Finetek USA, Inc

Statistics for Sakura Finetek USA, Inc

Market presence of Sakura Finetek USA, Inc

Devices by risk class

Device catalog for Sakura Finetek USA, Inc

Device families (Basic UDI-DI) of Sakura Finetek USA, Inc