Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004016971

FEI Number

3004016971

Entity Name

MECHATRONICS USA

City/State/Country

WARWICK, RI, US

Establishment Address

20 ALTIERI WAY UNIT 4, WARWICK, RI 02886, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

RR Mechatronics Manufacturing B.V. (Owner Number: 9038894)

Owner / Operator Contact Address

DE CORANTIJN 13, --, ZWAAG, NL-NOTA NL-1689 AN, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

STARRSED CONTROLS STARRSED RS STARRSED ST STARRSED RL STARRSED TL STARRSED INTERRLINER Starrsed Saline Starrsed Disinfectant Starrsed Cleaning agent STARRSED NSTA Starrsed Rinse Solution Starrsed X-Clean Starrsed ILXS Starrsed Diluent

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GKB	Device, Automated Sedimentation Rate	Hematology	Class 1	864.5800	1999-08-27
GIF	Diluent, Blood Cell	Hematology	Class 1	864.8200	2023-07-10

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

RR Mechatronics Manufacturing B.V.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004016977	RR MECHATRONICS Manufacturing B.V.	ZWAAG Noord-Holland, NL

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3006988008	ALIFAX SRL	Nimis Udine, IT
3004016977	RR MECHATRONICS Manufacturing B.V.	ZWAAG Noord-Holland, NL
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004016971. Last updated year: 2026. Please use registration number 3004016971 when referencing this establishment in official correspondence.