Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021389305

FEI Number

3021389305

Entity Name

SUNRISE TECHNOLOGIES, S.A.U.

City/State/Country

Sant Esteve Sesrovires Barcelona, ES

Establishment Address

Ronda Can Margarit, 38, Sant Esteve Sesrovires Barcelona 08635, ES

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SUNRISE TECHNOLOGIES, S.A.U. (Owner Number: 10083966)

Owner / Operator Contact Address

Ronda Can Margarit, 38, Pol. Ind. Can Margarit, Sant Esteve Sesrovires, ES-B 08635, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

INSTRUMENT SYSTEM CUVETTES

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2022-01-05

Official Correspondent

Javier Pineiro

US Agent Details

Constance Bridges Business: INOVA DIAGNOSTICS Email: cbridges@werfen.com Phone: (858) 6529224

Related Public Records

Same Entity

SUNRISE TECHNOLOGIES, S.A.U.

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-0027-2018	Hologic, Inc	2	Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021389305. Last updated year: 2026. Please use registration number 3021389305 when referencing this establishment in official correspondence.