Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009185248

FEI Number

3009185248

Entity Name

Ruhof (Hangzhou) Bio Tech Co.,Ltd

City/State/Country

310053 Zhejiang, CN

Establishment Address

No.3391, Nanhuan Road, Binjiang District, 310053 Zhejiang Hangzhou, CN

Establishment Type(s)

Foreign Private Label Distributor

Owner / Operator

The Ruhof Corporation (Owner Number: 10038187)

Owner / Operator Contact Address

393 Sagamore Avenue, 130-45 180th Jamaica NY 11434, Mineola, NY 11501, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

345SVECOS Endozime Ultimate SC Premixslip Liquciclean-H ACTS Surgislip Delyme Rinse Aid Endozime Premium SC Endozime AW Triple Plus w/APA Endozime ECO Bedside Kit CleanStart Bedside kit Endozime Sponge Mini Endozime SLR CleanStart Bedside Kit Prepzyme XF EZ Edo-Clean Bedside Kit Prepzyme Orthozime Endozime AW Plus Endozime SLR Phase One Endozime SLR Sponge Endozime Xtreme Power Endozime Premium w/APA Endozime Bio-Clean Endozime Sponge Surgistain G4SVECOLF Advance Cleaning Solution Advance Cleaning Solutions 345EBK500 345EBKNA500 G4SVECOLRF 345EBK

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	2011-09-22

Official Correspondent

Christopher Smith

US Agent Details

Douglas MacKay Email: dmackay@ruhof.com Phone: (516) 4267836

Related Public Records

Same Entity

The Ruhof Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003207991	THE RUHOF CORPORATION	Mineola, NY, US

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2025	Young Dental Manufacturing I, LLC	1	BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009185248. Last updated year: 2026. Please use registration number 3009185248 when referencing this establishment in official correspondence.