INDUSTRIA COLOMBIANA DE DOTACIONES METALICAS-DOMETAL S.A.S

FDA Device Registration & Listing · Medellin Antioquia, CO · Registration 3011537487

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011537487
FEI Number
3011537487
Entity Name
INDUSTRIA COLOMBIANA DE DOTACIONES METALICAS-DOMETAL S.A.S
City/State/Country
Medellin Antioquia, CO
Establishment Address
Calle 2 No. 50-185, Medellin Antioquia 000000, CO
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Industria Colombiana de Dotaciones Metalicas-Dometal S.A.S (Owner Number: 10048514)
Owner / Operator Contact Address
Calle 2 No. 50-185, Medellin, CO-ANT 000000, CO
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

MUBI STAINLESS MAYO MUBI STAINLESS MAYO TABLE MUBI Lynix Mixar Fenix Anfrix Pyxis Quaxar POLARIX pediatric bed PUENTE NOCHE NOVA MONODOSE MUBI HG MAY EMERGENCY PROFFESIONAL HAMILTON ET-600 GENOVA SYRIUX MILANO HELP IXYS CIGNUX HYDRUX LYRAX POLUX Clinical Stretcher TS-700 MUBI IRIS MUBI MAXCARE KRONOS FIRENZE GENOVA UNIKA MUBI Mubi Medical IV Pole YXIS

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2025-03-19
GDC Table, Operating-Room, Electrical General, Plastic Surgery Class 1 878.4960 2020-09-12
FNL Bed, Ac-Powered Adjustable Hospital General Hospital Class 2 880.5100 2015-01-21
BZN Cart, Emergency, Cardiopulmonary (Excluding Equipment) Anesthesiology Class 1 868.6175 2020-09-12
INW Table, Mechanical Physical Medicine Class 1 890.3750 2020-09-12
INO Chair, Positioning, Electric Physical Medicine Class 2 890.3110 2020-09-12
FPO Stretcher, Wheeled General Hospital Class 2 880.6910 2015-01-21
INN Chair, Adjustable, Mechanical Physical Medicine Class 1 890.3100 2020-09-12
IKY Mattress, Flotation Therapy, Non-Powered General Hospital Class 1 880.5150 2020-09-12
FOX Stand, Infusion General Hospital Class 1 880.6990 2025-03-24
INQ Table, Powered Physical Medicine Class 1 890.3760 2020-09-12

Official Correspondent

Carlos Trujillo Angel

US Agent Details

Jon Ward Business: AJW Technology Consultants, Inc Email: Usagent@Ajwtech.com Phone: (813) 6452855

Related Public Records

Same Entity

Industria Colombiana de Dotaciones Metalicas-Dometal S.A.S
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
K935837 Healthcare Designs AIRHYTHM HEALTHCARE BED 1994-06-21

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0027-2016 Zimmer, Inc. 1
Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0016-2007 Sunrise Medical CCG, Inc. 2
Joerns Ultra Care 770 Model AC Powered Beds with model numbers U770, U770 AL , U770 GNDAL. Sunrise Medical, Long Term Care Division, 5001 Joerns Drive, Stevens Point, WI 54481 USA.
Z-0017-2007 Hill-Rom, Inc. 2
Hill-Rom VersaCare Hospital Bed with optional patient pendant P3207A01 or P3207A02; model P3200.
Z-0019-2015 Arjo Hospital Equipment AB Verkstadsvagen 2
ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.
Z-0026-2007 Extended Care Air Therapy Systems Inc 2
ECAT (Extended Care Air Therapy Systems) 2000 Safe Enclosure Bed

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3001397320 ROECHLING MEDICAL ROCHESTER L.P. Rochester, NY, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011537487. Last updated year: 2026. Please use registration number 3011537487 when referencing this establishment in official correspondence.
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