ROYAL CHEMICAL COMPANY

FDA Device Registration & Listing · Macedonia, OH, US · Registration 3003639674

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3003639674
FEI Number
3003639674
Entity Name
ROYAL CHEMICAL COMPANY
City/State/Country
Macedonia, OH, US
Establishment Address
8679 South Freeway Drive, Macedonia, OH 44056, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Royal Chemical Company (Owner Number: 10084285)
Owner / Operator Contact Address
8679 South Freeway Drive, Macedonia, OH 44056, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

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 2022-02-04

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Royal Chemical Company
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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 3003639674. Last updated year: 2026. Please use registration number 3003639674 when referencing this establishment in official correspondence.
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