Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004727093

FEI Number

3004727093

Entity Name

IIMED MEDICAL MEXICANA S. DE R.L. DE C.V.

City/State/Country

Reynosa Tamaulipas, MX

Establishment Address

Av. Mike Allen 1220, Edificio 5, Parque Industrial Reynosa Seccion Norte, Reynosa Tamaulipas 88788, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

IIMED MEDICAL MEXICANA S. DE R.L. DE C.V. (Owner Number: 10025109)

Owner / Operator Contact Address

Av. Mike Allen 1220, Edificio 5, Parque Industrial Reynosa Seccion Norte, Reynosa, MX-TAM 88788, MX

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ready-Fit-D-Guard SUB1 TEMP MAX 2.64 VasoPress DVT Garment Comfort Fit Dental Guard Ultracheck NDI Passive Spheres Cho-Pat Original Knee Strap Vaso Press DVT Foot Garment

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2024-05-21
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2020-07-31
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2016-06-17
FRZ	Device, Patient Transfer, Powered	General Hospital	Class 2	880.6775	2019-08-01
OBR	Mouthguard, Over-The-Counter	Unknown	Class U	N/A	2022-07-08
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2015-03-06
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2023-12-20
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2021-02-23
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2015-03-20
OED	Antimicrobial Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2019-05-20
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2015-04-14
OBR	Mouthguard, Over-The-Counter	Unknown	Class U	N/A	2022-07-15
KNN	Components, Wheelchair	Physical Medicine	Class 1	890.3920	2019-12-11
KZD	Infusor, Pressure, For I.V. Bags	General Hospital	Class 1	880.5420	2010-01-14
FCM	Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)	Gastroenterology, Urology	Class 2	876.5130	2015-06-04
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2015-06-04
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2016-07-15
FEN	Device, Cystometric, Hydraulic	Gastroenterology, Urology	Class 2	876.1620	2013-04-26
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2024-05-21
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2015-02-27
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2023-10-11
EMB	Zinc Oxide Eugenol	Dental	Class 1	872.3275	2022-07-15
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2016-06-17
IKY	Mattress, Flotation Therapy, Non-Powered	General Hospital	Class 1	880.5150	2020-02-24
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2019-11-20
LBE	Stroller, Adaptive	Physical Medicine	Class 1	890.3850	2020-07-31
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2012-05-17
KPJ	Chamber, Oxygen, Topical, Extremity	General, Plastic Surgery	Class 2	878.5650	2018-07-16
INM	Chair, With Casters	Physical Medicine	Class 1	890.3100	2020-07-31
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2013-02-08
EBO	Denture Repair Kit	Dental	Class 2	872.3570	2024-03-19
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2015-11-02
KCY	Tourniquet, Pneumatic	General, Plastic Surgery	Class 1	878.5910	2021-10-20
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2018-12-10
KIC	Cushion, Flotation	Physical Medicine	Class 1	890.3175	2021-08-31
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2016-06-16
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2014-08-06
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2023-08-21
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2015-04-14
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2018-04-09
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2023-12-20
HIR	Perineometer	Obstetrics/Gynecology	Class 2	884.1425	2015-08-18
LKF	Cannula, Manipulator/Injector, Uterine	Obstetrics/Gynecology	Class 2	884.4530	2017-07-11
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2022-07-15
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2017-06-21
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2019-05-31
OBR	Mouthguard, Over-The-Counter	Unknown	Class U	N/A	2022-07-15
IQJ	Splint, Clavicle	Physical Medicine	Class 1	890.3490	2015-03-03
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2015-07-09
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2016-10-28
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2009-10-07
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2018-11-19
NXZ	Dental Hygiene Kit	Dental	Class 1	872.6855	2022-09-23
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2023-12-20
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2013-03-14
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2025-12-30
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2013-02-08

Official Correspondent

No official correspondent registered.

US Agent Details

ROBBIE ROARK Business: CORDICA MEDICAL Email: robbie.roark@cordicamedical.com Phone: (423) 5347083

Related Public Records

Same Entity

IIMED MEDICAL MEXICANA S. DE R.L. DE C.V.

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
K170216	Tactile Systems Technology, Inc. (Dba Tactile Medical)	Flexitouch System	2017-05-26
K100306	Covidien	KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES	2010-05-04
K935211	Brookefield Hunter, Inc.	WALK N CHAIR	1994-02-02
K832685	Health America	WHEELCHAIR-VARIOUS MODELS	1983-09-20
K033719	C.R. Bard, Inc.	BARD TIGERTAIL URETERAL CATHETER	2004-02-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2008	Lemaitre Vascular, Inc.	2	CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC)
Z-0039-05	Medrad Inc	2	Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT
Z-0010-2013	C.R. Bard, Inc., Urological Division	2	8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.
Z-0009-2013	Accuro Medical Product LLC	2	Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854 Hitchcock Ave, Downers Grove, IL 60515; part number 84635400182, sold inside the Apex Negative Wound Therapy system, part number 84635400181 Promotes wound healing through drainage and removal of infectious material and other fluids from the wound site using continuous and/or intermittent negative pressure. Types of wounds indicated include diabetic/neuropathic ulcers, pressure ulcers, chronic wounds, acute wounds and dehisced wounds.
Z-0039-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004727093. Last updated year: 2026. Please use registration number 3004727093 when referencing this establishment in official correspondence.