Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022114827

FEI Number

3022114827

Entity Name

RONEXMED S.A.S.

City/State/Country

Barranquilla Atlantico, CO

Establishment Address

CL 81 No. 56 - 21, Barranquilla Atlantico 080012, CO

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Ronexmed S.A.S. (Owner Number: 10084643)

Owner / Operator Contact Address

CL 81 No. 56 - 21, Barranquilla, CO-ATL 080012, CO

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Burn Sheet MedSource 4 Piece Linen Set MedSource Barrier Sheet MedSource Heavy Duty Cot with Pouch MedSource Cot Sheet, Fitted MedSource 3 Piece Linen Set MedSource Cot Sheet, Sewn Ends MedSource Cot Sheet, Flat MedSource Pro Fitted Heavy Duty Cot Sheet MedSource Ready Fit, Fitted Sheet MedSource Cot Sheet MedSource Burn Sheet MedSource Heavy Duty Cot Sheet with Square Ends MedSource Poly Tissue Disposable Sheet MedSource Specialty Cot Sheet MedSource Emergency Blanket MedSource Heavy Duty Cot Sheet Ready fit Patient mover rescue chair MedSource Patient Mover Plus MedSource Patient Mover

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FPY	Sheet, Burn	General Hospital	Class 1	880.5180	2025-02-20
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2022-03-16
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2022-03-16

Official Correspondent

No official correspondent registered.

US Agent Details

Emilie Andrews Business: MedSource International, LLC. Email: eandrews@medsourcelabs.com Phone: (952) 4720131

Related Public Records

Same Entity

Ronexmed S.A.S.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022114827. Last updated year: 2026. Please use registration number 3022114827 when referencing this establishment in official correspondence.