Data / Medical devices / Mexico / Iimed Medical Mexicana S. De R.L. De C.V.
Iimed Medical Mexicana S. De R.L. De C.V.: FDA-registered device maker in Reynosa Tamaulipas, Mexico, 1 510(k) clearance
Iimed Medical Mexicana S. De R.L. De C.V. is registered with the FDA (registration 3004727093) in Reynosa Tamaulipas, Mexico. It lists 61 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 4, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004727093
- Address
- Av. Mike Allen 1220, Edificio 5 Parque Industrial Reynosa Seccion Norte, Reynosa Tamaulipas, Mexico, 88788
- Owner or operator
- IIMED MEDICAL MEXICANA S. DE R.L. DE C.V. (10025109)
- Roles
- Complaint file establishment, Contract manufacturer, Repackager or relabeler
- First device listed
- October 7, 2009
- Registered through
- 2026
- Brand names listed
- Cho-Pat Original Knee Strap, Comfort Fit Dental Guard, NDI Passive Spheres, Ready-Fit-D-Guard, SUB1 TEMP MAX 2.64, Ultracheck, Vaso Press DVT Foot Garment, VasoPress DVT Garment
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Cleaning Brushes, For Endoscope | MNL | 1 | Complaint file establishment, Contract manufacturer | accessdata.fda.gov |
| Aid, Transfer | IKX | 1 | Complaint file establishment, Contract manufacturer | accessdata.fda.gov |
| Antimicrobial Blood Pressure Cuff | OED | 2 | Contract manufacturer | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Complaint file establishment, Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bandage, Elastic | FQM | 1 | Complaint file establishment, Contract manufacturer | accessdata.fda.gov |
| Binder, Medical, Therapeutic | MDR | 1 | Complaint file establishment, Contract manufacturer | accessdata.fda.gov |
| Blood Pressure Cuff | DXQ | 2 | Contract manufacturer | accessdata.fda.gov |
| Cannula, Manipulator/Injector, Uterine | LKF | 2 | Contract manufacturer | accessdata.fda.gov |
| Catheter And Tip, Suction | JOL | 2 | Complaint file establishment, Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Catheter, Irrigation | GBX | 1 | Complaint file establishment, Contract manufacturer | accessdata.fda.gov |
| Catheter, Urological | KOD | 2 | Contract manufacturer | accessdata.fda.gov |
| Chair, With Casters | INM | 1 | Contract manufacturer | accessdata.fda.gov |
| Chamber, Oxygen, Topical, Extremity | KPJ | 2 | Contract manufacturer | accessdata.fda.gov |
| Components, Wheelchair | KNN | 1 | Complaint file establishment, Contract manufacturer | accessdata.fda.gov |
| Cover, Mattress (Medical Purposes) | FMW | 1 | Complaint file establishment, Contract manufacturer | accessdata.fda.gov |
| Cushion, Flotation | KIC | 1 | Complaint file establishment, Contract manufacturer | accessdata.fda.gov |
| Cushion, Wheelchair | IMP | 1 | Complaint file establishment, Contract manufacturer | accessdata.fda.gov |
| Dental Hygiene Kit | NXZ | 1 | Complaint file establishment, Contract manufacturer | accessdata.fda.gov |
| Device, Cystometric, Hydraulic | FEN | 2 | Complaint file establishment, Contract manufacturer | accessdata.fda.gov |
| Device, Fixation, Tracheal Tube | CBH | 1 | Complaint file establishment, Contract manufacturer | accessdata.fda.gov |
| Device, Patient Transfer, Powered | FRZ | 2 | Complaint file establishment, Contract manufacturer | accessdata.fda.gov |
| Device, Transfer, Patient, Manual | FMR | 1 | Complaint file establishment, Contract manufacturer | accessdata.fda.gov |
| Dispenser, Liquid Medication | KYX | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Dressing, Compression | MHW | 1 | Complaint file establishment, Contract manufacturer | accessdata.fda.gov |
| Endoscopic Bite Block | MNK | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Evacuator, Oral Cavity | EHZ | 1 | Complaint file establishment, Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Infusor, Pressure, For I.V. Bags | KZD | 1 | Complaint file establishment, Contract manufacturer | accessdata.fda.gov |
| Injector And Syringe, Angiographic | DXT | 2 | Contract manufacturer | accessdata.fda.gov |
| Lift, Patient, Non-Ac-Powered | FSA | 1 | Complaint file establishment, Contract manufacturer | accessdata.fda.gov |
| Massager, Powered Inflatable Tube | IRP | 2 | Contract manufacturer | accessdata.fda.gov |
| Mattress, Flotation Therapy, Non-Powered | IKY | 1 | Complaint file establishment, Contract manufacturer | accessdata.fda.gov |
| Mouthguard, Over-The-Counter | OBR | U | Contract manufacturer | accessdata.fda.gov |
| Nebulizer (Direct Patient Interface) | CAF | 2 | Repackager or relabeler | accessdata.fda.gov |
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | 2 | Contract manufacturer | accessdata.fda.gov |
| Neurological Stereotaxic Instrument | HAW | 2 | Contract manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Complaint file establishment, Contract manufacturer | accessdata.fda.gov |
| Orthopedic Stereotaxic Instrument | OLO | 2 | Contract manufacturer | accessdata.fda.gov |
| Orthosis, Abdominal | KTD | 1 | Complaint file establishment, Contract manufacturer | accessdata.fda.gov |
| Orthosis, Cervical | IQK | 1 | Complaint file establishment, Contract manufacturer | accessdata.fda.gov |
| Orthosis, Limb Brace | IQI | 1 | Complaint file establishment, Contract manufacturer | accessdata.fda.gov |
| Orthosis, Lumbar | IQE | 1 | Complaint file establishment, Contract manufacturer | accessdata.fda.gov |
| Orthosis, Truncal/Orthosis, Limb | MRI | 1 | Complaint file establishment, Contract manufacturer | accessdata.fda.gov |
| Pack, Heat, Moist | IMA | 1 | Contract manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Disposable | IMD | 1 | Complaint file establishment, Contract manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Complaint file establishment, Contract manufacturer | accessdata.fda.gov |
| Patient Personal Hygiene Kit | NSB | 1 | Complaint file establishment, Contract manufacturer | accessdata.fda.gov |
| Perineometer | HIR | 2 | Contract manufacturer | accessdata.fda.gov |
| Protector, Skin Pressure | FMP | 1 | Complaint file establishment, Contract manufacturer | accessdata.fda.gov |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | 1 | Complaint file establishment, Contract manufacturer | accessdata.fda.gov |
| Sleeve, Limb, Compressible | JOW | 2 | Contract manufacturer | accessdata.fda.gov |
| Splint, Clavicle | IQJ | 1 | Complaint file establishment, Contract manufacturer | accessdata.fda.gov |
| Stroller, Adaptive | LBE | 1 | Contract manufacturer | accessdata.fda.gov |
| Support, Patient Position | CCX | 1 | Complaint file establishment, Contract manufacturer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Contract manufacturer | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Complaint file establishment, Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tourniquet, Pneumatic | KCY | 1 | Complaint file establishment, Contract manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Contract manufacturer | accessdata.fda.gov |
| Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | FCM | 2 | Contract manufacturer | accessdata.fda.gov |
| Ventilator, Non-Continuous (Respirator) | BZD | 2 | Contract manufacturer | accessdata.fda.gov |
| Wheelchair, Mechanical | IOR | 1 | Contract manufacturer | accessdata.fda.gov |
| Zinc Oxide Eugenol | EMB | 1 | Complaint file establishment, Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 4, 2024 | K231058 | Hudson RCI® AddiPak® Unit Dose Vial | CAF | Substantially Equivalent | Medline Industries, LP | accessdata.fda.gov |
Compare with other makers
- All makers of Mouthguard, Over-The-Counter
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Set, Tubing And Support, Ventilator (W Harness)
- All makers of Cushion, Wheelchair
- All makers of Evacuator, Oral Cavity
- All makers of Sleeve, Limb, Compressible
Updated January 4, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.