Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013164281

FEI Number

3013164281

Entity Name

SCREENTEC OY

City/State/Country

Oulu, Finland Pohjois-Pohjanmaa, FI

Establishment Address

Konekuja 2, Oulu, Finland Pohjois-Pohjanmaa 90620, FI

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Screentec Oy (Owner Number: 10095141)

Owner / Operator Contact Address

Konekuja 2, Oulu, Finland, FI-14 90620, FI

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Otsuka Digital Feedback Device

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	Class 2	870.2920	2026-01-28

Official Correspondent

Antti Tauriainen

US Agent Details

Michael Fahmy Email: michael.fahmy@otsuka-us.com Phone: (609) 5359659

Related Public Records

Same Entity

Screentec Oy

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K820986	Dart Medical Equipment	EKG MONITORS, VARIOUS MODELS	1982-04-29
K910450	Medtech Industries, Inc.	CARD GUARD-3000 ECG TELEPHONE ADAPTER	1991-05-07
K761318	Cambridge Instruments, Inc.	3038 OPTION B-COMPUT. TRANS. TERMINAL	1977-01-06
K972649	Reynolds Medical , Ltd.	CARDIOCALL CARDIAC EVENT RECORDER	1997-12-04
K033410	Remote Diagnostic Technologies , Ltd.	TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002	2004-03-05

Similar Registrations

Registration Number	Establishment Name	Location
3013250653	MASIMO CORPORATION	Irvine, CA, US
3015976873	QOMPIUM NV	Hasselt Limburg, BE
3010742884	Otsuka America Pharmaceutical, Inc	Hayward, CA, US
3042928308	TAIWAN SCIENTIFIC CORPORATION	New Taipei, TW
3017884848	KITRON TECHNOLOGIES INC.	Windber, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013164281. Last updated year: 2026. Please use registration number 3013164281 when referencing this establishment in official correspondence.