Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004016977

FEI Number

3004016977

Entity Name

RR MECHATRONICS Manufacturing B.V.

City/State/Country

ZWAAG Noord-Holland, NL

Establishment Address

DE CORANTIJN 13, ZWAAG Noord-Holland NL-1689 AN, NL

Establishment Type(s)

Manufacture 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 RPI-Check 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
JCE	Solution, Isotonic	Pathology	Class 1	864.4010	2021-12-21
GIF	Diluent, Blood Cell	Hematology	Class 1	864.8200	2023-07-10

Official Correspondent

No official correspondent registered.

US Agent Details

Stephen Barr Business: MECHATRONICS USA Email: sbarr@mechatronicsusa.com Phone: (401) 4316101

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
3004016971	MECHATRONICS USA	WARWICK, RI, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004016977. Last updated year: 2026. Please use registration number 3004016977 when referencing this establishment in official correspondence.