Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008058231

FEI Number

3008058231

Entity Name

LINET spol. s r.o.

City/State/Country

Slany Stredocesky Kraj, CZ

Establishment Address

Zelevcice 5, Slany Stredocesky Kraj 27401, CZ

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

LINET LLC (Owner Number: 10030685)

Owner / Operator Contact Address

Zelevcice 5, Slany, CZ-203 27401, CZ

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Tom 2 Protevo APC Protevo GTE OptiCare OptiCare X Protevo GTE+MCM Protevo ST HybriMatt Sprint 400 Sprint 200 Mano AVE 2 AVE 2 with Vibwife Vibwife CliniCare 10P Ergozone SprintMatt Multicare with Symbioso Multicare X with OptiCare X Multicare with OptiCare Eleganza 5 with OptiCare Sprint 100 Sprint 200 Sprint 400

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMS	Bed, Pediatric Open Hospital	General Hospital	Class 2	880.5140	2017-01-06
FNM	Mattress, Air Flotation, Alternating Pressure	General Hospital	Class 2	880.5550	2015-02-09
INK	Stretcher, Wheeled, Powered	Physical Medicine	Class 2	890.3690	2022-05-10
KMN	Chair And Table, Medical	General Hospital	Class 1	880.6140	2017-05-04
HDD	Table, Obstetrical, Ac-Powered (And Accessories)	Obstetrics/Gynecology	Class 2	884.4900	2017-07-10
IKY	Mattress, Flotation Therapy, Non-Powered	General Hospital	Class 1	880.5150	2017-06-30
IOQ	Bed, Flotation Therapy, Powered	Physical Medicine	Class 2	890.5170	2015-02-09
FPO	Stretcher, Wheeled	General Hospital	Class 2	880.6910	2018-02-09

Official Correspondent

Jan Sterba

US Agent Details

Steve Krueger Business: MAK and Associates, LLC Email: steve@makcompliance.com Phone: (262) 8946427

Related Public Records

Same Entity

LINET LLC

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
K890935	Dermanetics Corp.	SYSTEM 3000 FLUIDIZED AIR BED	1989-03-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0023-05	Stryker Medical	2	Stryker brand Rugged EZ-Pro R4 Ambulance Cot, model 6092.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008058231. Last updated year: 2026. Please use registration number 3008058231 when referencing this establishment in official correspondence.