FDA Registration
Active
🇲🇽 Mexico
IIMED MEDICAL MEXICANA S. DE R.L. DE C.V.
Reg #: 3004727093
·
FEI: 3004727093
·
Expires 2026
Products
64
Proprietary Names
8
Establishment Types
3
Classifications
64
Registration Details
- Registration Name
- IIMED MEDICAL MEXICANA S. DE R.L. DE C.V.
- Registration Number
- 3004727093
- FEI Number
- 3004727093
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Av. Mike Allen 1220, Edificio 5, Parque Industrial Reynosa Seccion Norte
- City
- Reynosa Tamaulipas
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K231058
Owner / Operator
- Firm Name
- IIMED MEDICAL MEXICANA S. DE R.L. DE C.V.
- Operator Number
- 10025109
- Address
- Av. Mike Allen 1220, Edificio 5, Parque Industrial Reynosa Seccion Norte
- City
- Reynosa
- State
- Tamaulipas
- Postal Code
- 88788
- Country
- MX
US Agent
- Business Name
- CORDICA MEDICAL
- Contact Name
- ROBBIE ROARK
- Address
- 800 S Gay St
- City
- Knoxville
- State
- TN
- ZIP
- 37929
- Country
- US
- [email protected]
- Phone
- 423 5347083
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sleeve, Limb, Compressible | JOW | Class 2 | Cardiovascular | No | 2024-05-21 |
| Wheelchair, Mechanical | IOR | Class 1 | Physical Medicine | No | 2020-07-31 |
| Injector And Syringe, Angiographic | DXT | Class 2 | Cardiovascular | No | 2016-06-17 |
| Device, Patient Transfer, Powered | FRZ | Class 2 | General Hospital | No | 2019-08-01 |
| Mouthguard, Over-The-Counter | OBR | Class U | Unknown | No | 2022-07-08 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2015-03-06 |
| Evacuator, Oral Cavity | EHZ | Class 1 | Dental | No | 2023-12-20 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2021-02-23 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2015-03-20 |
| Antimicrobial Blood Pressure Cuff | OED | Class 2 | Cardiovascular | No | 2019-05-20 |
| Device, Fixation, Tracheal Tube | CBH | Class 1 | Anesthesiology | No | 2015-04-14 |
| Components, Wheelchair | KNN | Class 1 | Physical Medicine | No | 2019-12-11 |
| Infusor, Pressure, For I.V. Bags | KZD | Class 1 | General Hospital | No | 2010-01-14 |
| Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | FCM | Class 2 | Gastroenterology, Urology | No | 2015-06-04 |
| Catheter, Urological | KOD | Class 2 | Gastroenterology, Urology | No | 2015-06-04 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2016-07-15 |
| Device, Cystometric, Hydraulic | FEN | Class 2 | Gastroenterology, Urology | No | 2013-04-26 |
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | Class 2 | General, Plastic Surgery | No | 2023-10-11 |
| Zinc Oxide Eugenol | EMB | Class 1 | Dental | No | 2022-07-15 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2016-06-17 |
| Mattress, Flotation Therapy, Non-Powered | IKY | Class 1 | General Hospital | No | 2020-02-24 |
| Stroller, Adaptive | LBE | Class 1 | Physical Medicine | No | 2020-07-31 |
| Chamber, Oxygen, Topical, Extremity | KPJ | Class 2 | General, Plastic Surgery | No | 2018-07-16 |
| Chair, With Casters | INM | Class 1 | Physical Medicine | No | 2020-07-31 |
| Denture Repair Kit | EBO | Class 2 | Dental | No | 2024-03-19 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2015-11-02 |
| Tourniquet, Pneumatic | KCY | Class 1 | General, Plastic Surgery | No | 2021-10-20 |
| Cushion, Flotation | KIC | Class 1 | Physical Medicine | No | 2021-08-31 |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | Class 1 | Anesthesiology | No | 2014-08-06 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2023-08-21 |
| Aid, Transfer | IKX | Class 1 | Physical Medicine | No | 2015-04-14 |
| Endoscopic Bite Block | MNK | Class 1 | Gastroenterology, Urology | No | 2023-12-20 |
| Perineometer | HIR | Class 2 | Obstetrics/Gynecology | No | 2015-08-18 |
| Cannula, Manipulator/Injector, Uterine | LKF | Class 2 | Obstetrics/Gynecology | No | 2017-07-11 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2022-07-15 |
| Device, Transfer, Patient, Manual | FMR | Class 1 | General Hospital | No | 2017-06-21 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2019-05-31 |
| Splint, Clavicle | IQJ | Class 1 | Physical Medicine | No | 2015-03-03 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2016-10-28 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2009-10-07 |
| Dental Hygiene Kit | NXZ | Class 1 | Dental | No | 2022-09-23 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2023-12-20 |
| Orthosis, Truncal/Orthosis, Limb | MRI | Class 1 | Physical Medicine | No | 2013-03-14 |
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2025-12-30 |
| Patient Personal Hygiene Kit | NSB | Class 1 | Dental | No | 2024-01-02 |
| Binder, Medical, Therapeutic | MDR | Class 1 | General Hospital | No | 2015-03-06 |
| Cushion, Wheelchair | IMP | Class 1 | Physical Medicine | No | 2017-03-08 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2016-06-10 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2016-09-14 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2015-03-13 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2013-02-15 |
| Lift, Patient, Non-Ac-Powered | FSA | Class 1 | General Hospital | No | 2015-03-13 |
| Ventilator, Non-Continuous (Respirator) | BZD | Class 2 | Anesthesiology | No | 2015-11-02 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2023-12-20 |
| Reliner, Denture, Over The Counter | EBP | Class 2 | Dental | No | 2024-03-19 |
| Pack, Heat, Moist | IMA | Class 1 | Physical Medicine | No | 2018-04-09 |
| Orthosis, Abdominal | KTD | Class 1 | Physical Medicine | No | 2015-03-06 |
| Cover, Mattress (Medical Purposes) | FMW | Class 1 | General Hospital | No | 2016-06-06 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2020-11-27 |
| Cement, Dental | EMA | Class 2 | Dental | No | 2024-03-19 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 2024-02-27 |
| Dressing, Compression | MHW | Class 1 | General Hospital | No | 2015-03-06 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2013-08-05 |
| Massager, Powered Inflatable Tube | IRP | Class 2 | Physical Medicine | No | 2015-08-25 |
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
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device