FDA Registration
Active
🇲🇽 Mexico
NOVEM MEDICAL S. DE R.L. DE C.V.
Reg #: 3012187635
·
FEI: 3012187635
·
Expires 2026
Products
27
Proprietary Names
25
Establishment Types
1
Classifications
27
Registration Details
- Registration Name
- NOVEM MEDICAL S. DE R.L. DE C.V.
- Registration Number
- 3012187635
- FEI Number
- 3012187635
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- CALLE AMAPOLAS 19380, COL LIBRAMIENTO
- City
- TIJUANA Baja California
- Country
- MX
Owner / Operator
- Firm Name
- NOVEM MEDICAL S. DE R.L. DE C.V.
- Operator Number
- 10049894
- Address
- Calle Amapolas 19380, Col Libramiento
- City
- TIJUANA
- State
- Baja California
- Postal Code
- 22225
- Country
- MX
- Correspondent
- ENRIQUE CASTRO
US Agent
- Business Name
- Primary Packaging
- Contact Name
- John Barron
- Address
- 26945 Cabot Road # 101
- City
- Laguna Hills
- State
- CA
- ZIP
- 92653
- Country
- US
- [email protected]
- Phone
- 949 2947077
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2018-09-14 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2025-02-11 |
| Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | GQG | Class 1 | Microbiology | No | 2021-10-29 |
| Elastomer, Silicone, For Scar Management | MDA | Class 1 | General, Plastic Surgery | No | 2023-04-13 |
| Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile | NNY | Class 1 | Gastroenterology, Urology | No | 2020-02-18 |
| Device, Fixation, Tracheal Tube | CBH | Class 1 | Anesthesiology | No | 2018-12-18 |
| Syringe, Ent | KCP | Class 1 | Ear, Nose, Throat | No | 2017-07-23 |
| Spill Kit | PXG | Class 1 | General Hospital | No | 2024-04-04 |
| Marker, Skin | FZZ | Class 1 | General, Plastic Surgery | No | 2016-09-14 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2018-08-01 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2026-04-07 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 2019-08-09 |
| Pneumotachometer | JAX | Class 2 | Anesthesiology | No | 2019-07-28 |
| Scalp Cooling System | PMC | Class 2 | General, Plastic Surgery | No | 2023-08-11 |
| Pad, Heating, Powered | IRT | Class 2 | Physical Medicine | No | 2023-05-04 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2019-08-09 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2022-07-04 |
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | Class 1 | Clinical Chemistry | No | 2023-11-06 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2023-05-04 |
| Basin, Emesis | FNY | Class 1 | General Hospital | No | 2017-07-23 |
| Scalpel, One-Piece | GDX | Class 1 | General, Plastic Surgery | No | 2024-03-25 |
| Unit, Cryosurgical, Accessories | GEH | Class 2 | General, Plastic Surgery | No | 2019-04-24 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | Class 1 | Anesthesiology | No | 2019-03-19 |
| Support, Breathing Tube | JAY | Class 1 | Anesthesiology | No | 2018-12-18 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 2023-05-30 |
| Label Or Tag, Sterile | LYV | Class 1 | General, Plastic Surgery | No | 2023-05-04 |
| Pack, Heat, Moist | IMA | Class 1 | Physical Medicine | No | 2024-04-11 |
Proprietary Names
Hope Nebulizer
Assy, Extract Reag QV SARS, VIAL QUIDEL
Pro-Sil Silicone Stick and Gel
Shur-In: S188811
ET Tape, LockTite
Ear Wash system Rigid and/or Flexible
SPILL KIT
Skin Marker - TIME OUT markers, Sandel Safety Marker
Q Flo Valve assembly
Weighted Safety Handle for Scalpel #20
Disarmer, scalpel disarmer
Accutach Flow Sensor
Portable Scalp Cooling System
PAD, HEATING, POWERED
DISARM-IT-ALL
Finger Compressor
CMLS-OPERATING ROOM W/CUPS
Stabiltube
TOPICAL SILICONE OINTMENT
Ear Wash Basin
Foam Applicators
NEO2 SAFE
Bite Block
120CC MEDICINE CUP AND LID
LABEL OR TAG, STERILE
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)