Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004070722

FEI Number

3004070722

Entity Name

ELLA-CS, S.R.O.

City/State/Country

Hradec Kralove, CZ

Establishment Address

Milady Horakove 504/45 Trebes, Hradec Kralove 500 06, CZ

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ELLA-CS, s.r.o. (Owner Number: 10046400)

Owner / Operator Contact Address

Milady Horakove 504/45, Trebes, Hradec Kralove, CZ-521 500 06, CZ

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2014-03-18
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2014-03-18
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2025-12-11

Official Correspondent

Jan Honegr

US Agent Details

Jeremy Smith Business: RAUMEDIC Inc. Email: Jeremy.Smith@raumedic.com Phone: (828) 4903262

Related Public Records

Same Entity

ELLA-CS, s.r.o.

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
K020558	Integra Neurosciences	LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE	2002-03-21

Similar Registrations

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3004593495	Plexus Manufacturing Sdn. Bhd.	Bayan Lepas Pulau Pinang, MY
3014334038	Integra LifeSciences Production Corporation	Mansfield, MA, US
3013944123	Eurofins Infinity Laboratory Group Inc.	San Jose, CA, US
3013886523	Integra LifeSciences Switzerland Sarl	Le Locle Neuchatel, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004070722. Last updated year: 2026. Please use registration number 3004070722 when referencing this establishment in official correspondence.