Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013889955

FEI Number

3013889955

Entity Name

SEMECS, S.R.O.

City/State/Country

Vrable Nitriansky, SK

Establishment Address

Hlavna 1797/62, Vrable Nitriansky 95201, SK

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Semecs (Owner Number: 10057935)

Owner / Operator Contact Address

Hlavna 1797/62, Vrable, SK-NI 95201, SK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Braemar Telemetry Patch System BTPS-1000, MCOT, Braemar Telemetry Patch System, BTPS-1000, ECG Recorder, BTP-1000M (Moni ePatch, ePatch ECG Recorder, ECG Recorder, ePatch 2 CardioKey, Model CK100

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2018-06-14
DSH	Recorder, Magnetic Tape, Medical	Cardiovascular	Class 2	870.2800	2018-06-14
MWJ	Electrocardiograph, Ambulatory (Without Analysis)	Cardiovascular	Class 2	870.2800	2018-06-14

Official Correspondent

Martin Zabransky

US Agent Details

Joey Egan Business: Syncron EMS Email: j.egan@syncron-ems.com Phone: (321) 4090025

Related Public Records

Same Entity

Semecs

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
K891148	Del Mar Avionics	MODEL 152 DELTA HOLTER ECG ANALYSIS SYSTEM	1989-05-11
K914092	Nihon Kohden America, Inc.	BSM-2100A CONFIGURED PATIENT MONITOR	1992-05-28
K153473	Braemar Manufacturing, LLC	Braemar Telemetry Patch System	2016-07-22
K151681	Philips Medizin Systeme Boeblingen GmbH	IntelliVue Patient Monitor	2015-07-17
K150310	Philips Medizin Systeme Boeblingen GmbH	IntelliVue Patient Monitor	2015-05-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2025	Philips North America	2	IntelliVue G7m Anesthesia Gas Module, Product Number 866173
Z-0030-05	General Electric Medical Systems Information Technology	2	GE CIC Central Station Monitoring Product, Versions 3.x, 4.0.5, 4.0.6
Z-0034-2011	Philips Medical Systems North America Co. Phillips	2	The device's marketing brochure states: "IntelliVue M3150 Information Center...Philips Medical Systems". The beige-colored PAS-210 external speakers can be identified by their use of DB15-to-3.5 mm mini-phone jack cable (Agispec-081Y-4 or Agispec-081-6) to connect to the rp5700 PC. Indicated for central monitoring of multiple adult, pediatric, and neonatal patients.
Z-0035-2025	Philips North America	2	Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1

Similar Registrations

Registration Number	Establishment Name	Location
3004574071	PERTECH INDUSTRIES, INC	Riverton, WY, US
3003584029	Braemar Manufacturing, LLC	San Diego, CA, US
3009077524	DHL SUPPLY CHAIN (NETHERLANDS) B.V.	Beringe Limburg, NL
3009499478	EDAN Diagnostics, Inc.	San Diego, CA, US
3013500228	Amphenol Cable and Interconnect Technologies Asia Pacific Ltd.	Tsimshatsui, Kowloon, HK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013889955. Last updated year: 2026. Please use registration number 3013889955 when referencing this establishment in official correspondence.