FDA Registration
Active
🇲🇽 Mexico
TECNOLOGIAS MEDICAS INNOVADORAS S DE RL
Reg #: 3003767629
·
FEI: 3003767629
·
Expires 2026
Products
6
Proprietary Names
19
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- TECNOLOGIAS MEDICAS INNOVADORAS S DE RL
- Registration Number
- 3003767629
- FEI Number
- 3003767629
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- CALLE 18 Y HERRERA No. 84, ZONA CENTRO,
- City
- H. MATAMOROS Tamaulipas
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K963924
Owner / Operator
- Firm Name
- PRE HOLDING, INC.
- Operator Number
- 9008012
- Address
- 2412 PARI Way, --
- City
- Midlothian
- State
- VA
- Postal Code
- 23112
- Country
- US
- Correspondent
- MICHAEL N JUDGE
US Agent
- Business Name
- PRE HOLDING, INC.
- Contact Name
- MICHAEL JUDGE
- Address
- 2412 PARI Way
- City
- MIDLOTHIAN
- State
- VA
- ZIP
- 23112
- Country
- US
- [email protected]
- Phone
- 804 2537274 ext. 269
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2005-03-07 |
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2012-03-13 |
| Spirometer, Therapeutic (Incentive) | BWF | Class 2 | Anesthesiology | No | 2017-05-31 |
| Applicator, Ent | KCJ | Class 1 | Ear, Nose, Throat | No | 2006-09-27 |
| Compressor, Air, Portable | BTI | Class 2 | Anesthesiology | No | 2005-09-28 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2006-09-15 |
Proprietary Names
Bubbles the Fish
LC Disposable
O-PEP
Vortex
LC Plus
Vios
Filter/Valve Set
NASAL SHOWER
PARI PEP
Trek S
SinuStar
Vios Pro
Proneb Ultra
Proneb Max
WING TIP TUBING
PARI Baby Nebulizer
PARI Sinus
PEP S
LC Sprint
Establishment Types
Manufacture Medical Device