FDA Registration
Active
🇲🇽 Mexico
VELCROMEX, S.A. DE C.V.
Reg #: 9680215
·
FEI: 3001084824
·
Expires 2026
Products
32
Proprietary Names
2
Establishment Types
1
Classifications
32
Registration Details
- Registration Name
- VELCROMEX, S.A. DE C.V.
- Registration Number
- 9680215
- FEI Number
- 3001084824
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- CALLE 13, AVES. 14 Y 17, No. 1545
- City
- AGUA PRIETA Sonora
- Country
- MX
Owner / Operator
- Firm Name
- VELCROMEX, S.A. DE C.V.
- Operator Number
- 9007245
- Address
- CALLE 13, AVES. 14 Y 17, #1545, --
- City
- AGUA PRIETA, SONORA
- State
- MX-NOTA
- Postal Code
- 84269
- Country
- MX
US Agent
- Business Name
- FISH & RICHARDSON P.C.
- Contact Name
- Keith Barritt
- Address
- 1000 Maine Ave. S.W., Suite 1000
- City
- WASHINGTON
- State
- DC
- ZIP
- 20024
- Country
- US
- [email protected]
- Phone
- 202 6266433
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Operating Room Accessories Table Tray | FWZ | Class 1 | General, Plastic Surgery | No | 2010-02-23 |
| Component, Cast | LGF | Class 1 | Orthopedic | No | 2014-12-08 |
| Support, Breathing Tube | JAY | Class 1 | Anesthesiology | No | 2009-06-18 |
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2023-09-05 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2023-09-05 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2023-09-05 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2023-09-05 |
| System, Network And Communication, Physiological Monitors | MSX | Class 2 | Cardiovascular | No | 2023-09-05 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2011-07-07 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2020-07-09 |
| Holder, Ureteral Catheter | EYJ | Class 1 | Gastroenterology, Urology | No | 2010-06-16 |
| Monitor, Apnea, Home Use | NPF | Class 2 | Anesthesiology | No | 2015-12-20 |
| Monitor, Bed Patient | KMI | Class 1 | General Hospital | No | 2019-12-18 |
| Restraint, Protective | FMQ | Class 1 | General Hospital | No | 2013-08-06 |
| Ventilator, Continuous, Facility Use | CBK | Class 2 | Anesthesiology | No | 2014-12-08 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2018-12-19 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2018-12-19 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2018-12-19 |
| Knee Arthroplasty Implantation System | OOG | Class 2 | Orthopedic | No | 2018-12-19 |
| Pad, Neonatal Eye | FOK | Class 1 | General Hospital | No | 2012-07-27 |
| Tourniquet, Pneumatic | KCY | Class 1 | General, Plastic Surgery | No | 2017-12-14 |
| Device, Fixation, Tracheal Tube | CBH | Class 1 | Anesthesiology | No | 2004-01-28 |
| System, Monitoring, Perinatal | HGM | Class 2 | Obstetrics/Gynecology | No | 2010-04-13 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2004-01-28 |
| Aid, Transfer | IKX | Class 1 | Physical Medicine | No | 2004-01-28 |
| Ventilator, Non-Continuous (Respirator) | BZD | Class 2 | Anesthesiology | No | 2013-07-01 |
| Orthosis, Sacroiliac, Soft | IPW | Class 1 | Physical Medicine | No | 2020-12-18 |
| Light, Headband, Surgical | FSR | Class 2 | Ophthalmic | No | 2014-12-08 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2004-09-29 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2004-01-28 |
| Strap, Head, Gas Mask | BTK | Class 1 | Anesthesiology | No | 2009-06-18 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2018-12-19 |
Proprietary Names
None created by Cardinal Health
ATOS FreeVent® Neckband two-piece with VELCRO® Brand fastening
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)