FDA Registration
Active
🇲🇽 Mexico
Polimeros Formula de Tecate S.A de C.V
Reg #: 1000484830
·
FEI: 1000484830
·
Expires 2026
Products
20
Proprietary Names
77
Establishment Types
1
Classifications
20
Registration Details
- Registration Name
- Polimeros Formula de Tecate S.A de C.V
- Registration Number
- 1000484830
- FEI Number
- 1000484830
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Guaycura No. 106, Col. El Paraiso
- City
- Tecate Baja California
- Country
- MX
Owner / Operator
- Firm Name
- Polimeros Formula de Tecate, SA de CV
- Operator Number
- 10054378
- Address
- Guaycura No. 106, Col. El Paraiso
- City
- Tecate
- State
- Baja California
- Postal Code
- 21485
- Country
- MX
- Correspondent
- Alejandro Mendez
US Agent
- Business Name
- Formula Plastics Inc
- Contact Name
- Bill Gerard
- Address
- 8800 N Gainey Center Dr Ste 176
- City
- Scottsdale
- State
- AZ
- ZIP
- 85258
- Country
- US
- [email protected]
- Phone
- 480 3445000
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2026-05-07 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2021-09-27 |
| Pressure Ulcer Management Tool | QEF | Class 1 | Gastroenterology, Urology | No | 2024-07-15 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2026-03-03 |
| Container, Specimen Mailer And Storage, Sterile | KDT | Class 1 | Pathology | No | 2022-11-01 |
| System, Thermal Regulating | DWJ | Class 2 | Cardiovascular | No | 2020-02-13 |
| Mouthpiece, Breathing | BYP | Class 1 | Anesthesiology | No | 2026-03-03 |
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2025-07-09 |
| Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | LJS | Class 2 | General Hospital | No | 2026-03-02 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2022-10-28 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2025-11-26 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2022-11-03 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2025-12-16 |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | Class 2 | Gastroenterology, Urology | No | 2025-07-09 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2025-02-17 |
| Connector, Airway (Extension) | BZA | Class 1 | Anesthesiology | No | 2026-03-02 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2024-03-14 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2026-03-03 |
| Trephine, Manual, Ophthalmic | HRH | Class 1 | Ophthalmic | No | 2024-03-19 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2026-03-10 |
Proprietary Names
Vascular Integrity, LLC Syringe, Piston - By-pass Syringe- Luer Access (VI-103-LC)
MEDLINE INDUSTRIES, LP
Bruin Biometrics, LLC
Respironics Novametrix, LLC CAPNOTRAK CO2 ORAL NASAL CANNULA (1105099)
Respironics Novametrix, LLC CAPNOTRAK CO2 NASAL CANNULA (1103410)
Respironics Novametrix, LLC CAPNOTRAK WATER FILTER ASSEMBLY (1103416)
Respironics Novametrix, LLC CANNULA, NASAL/ORAL CO2/O2 PEDIATRIC (1149488)
Respironics Novametrix, LLC CAPNOTRAK CO2/O2 NASAL CANNULA (1103411)
Respironics Novametrix, LLC CANNULA, NASAL/ORAL CO2/O2 ADULT (1149379)
Respironics Novametrix, LLC CAPNOTRAK CO2/O2 ORAL NASAL CANNULA (1105100)
Respironics Novametrix, LLC CAPNOTRAK CO2 ORAL NASAL CANNULA (1105098)
Respironics Novametrix, LLC CAPNOTRAK CO2 NASAL CANNULA (1103408)
Respironics Novametrix, LLC CANNULA NASAL CO2/O2 ADULT (1149480)
Respironics Novametrix, LLC CAPNOTRAK CO2/O2 NASAL CANNULA (1103412)
LIFE TECHNOLOGIES CORPORATION
AVACORE TECHNOLOGIES, INC.
Sontek Medical, LLC BITE BLOK A1009
ContraHealth Bronchoscope
Piccolo Medical, Inc Nav+ Guidance Set; PM2+ System, PMI-SUB-15-381, PMI-SUB-15-381
AMSINO MEDICAL (SHANGHAI) CO., LTD.
SPECTRUM VASCULAR
ACCUTEC BLADES, INC
Vascular Integrity, LLC Syringe, Piston FMF/Syringe, piston (VI-101-WM-B)
Vascular Integrity, LLC Syringe, Piston FMF/Syringe, piston (VI-101-WM-A)
Hologic, Inc.
Vascular Integrity, LLC Syringe, Piston - Syringe, Piston (VI-102-BC)
ContraHealth Ureteroscope
POROUS MORPHIX SUTURE ANCHOR WITH FORCE FIBER SUTURE
Respironics Novametrix, LLC Adapter Neonatal Disp Capnostat (1149448)
Sontek Medical, LLC Bronch-Safe: A1003, A1003B, A1003DHD, A2000; Suction-Safe: A1002, A1002B
Respironics Novametrix, LLC Adapter Adult DISP Capnostat (1149386)
Respironics Novametrix, LLC CapnoTrak Airway Adapter Set (1103415)
Respironics Novametrix, LLC SPU ADU Airway Adapter, Philips M2533A (1020711)
Respironics Novametrix, LLC CapnoTrak Airway Adapter Set (1103414)
Respironics Novametrix, LLC Adult DISP CO2 AA, Spacelabs (6946-00)
Respironics Novametrix, LLC SPU PED Adult A ADPTR W MTHPC (6421-00)
Respironics Novametrix, LLC SPU NEO-PED Airway Adapter (6312-00)
Respironics Novametrix, LLC SPU Ped-Adu Airway Adapter (6063-00)
Respironics Novametrix, LLC SPU Neonatal AIRWY ADPTR (1149339)
Respironics Novametrix, LLC SPU INF Airway Adapter, Philips M2536A (1020709)
Respironics Novametrix, LLC SPU 15mm Male/Female Adptr (8935-25)
Respironics Novametrix, LLC SPU Adult Airway ADPTR (1149466)
Medshape, Inc
Respironics Novametrix, LLC LoFlo Sampling Line Kit w/Dehumidification Tubing (1149495)
Respironics Novametrix, LLC LoFlo CO2 Sampling O2 Delivery Cannula ADULT NASAL (3469ADU-00)
Respironics Novametrix, LLC LoFlo CO2 Sampling O2 Delivery Cannula ADULT ORAL/NASAL (3471ADU-00)
Respironics Novametrix LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing ADULT ORAL/NASAL (3471ADH-00)
Respironics Novametrix, LLC LoFlo Sampling Line Kit (1149494)
Respironics Novametrix, LLC LoFlo CO2 Sampling Cannula ADULT NASAL (3468ADU-00)
Respironics Novametrix, LLC LoFlo Airway Adapter Kit w/Dehumidification Tubing INFANT/NEONATAL (3473INF-00)
Respironics Novametrix, LLC LoFlo CO2 Sampling Cannula PEDIATRIC NASAL (3468PED-00)
Respironics Novametrix, LLC LoFlo SAMPLING LINE KIT w/Dehumidification Tubing (3475-00)
Respironics Novametrix, LLC LoFlo Airway Adapter Kit w/ Dehumidification Tubing Adult/Pediatric (3473ADU-00)
Respironics Novametrix, LLC LoFlo CO2 Sampling O2 Delivery Cannula INFANT/NEONATAL NASAL (3469INF-00)
Respironics Novametrix, LLC LoFlo Airway Adapter Kit ADULT/PEDIATRIC (3472ADU-00)
Respironics Novametrix, LLC LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing ADULT NASAL (3469ADH-00)
Respironics Novametrix, LLC LoFlo CO2 Sampling O2 Delivery Cannula PEDIATRIC NASAL (3469PED-00)
Respironics Novametrix, LLC LoFlo CO2 Sampling Cannula (1149474)
Respironics Novametrix, LLC LoFlo CO2 Sampling Cannula with Dehumidification Tubing INFANT/NEONATAL NASAL (3468INH-00)
Respironics Novametrix, LLC LoFlo SAMPLING LINE KIT (3474-00)
Respironics Novametrix, LLC LoFlo CO2 Sampling Cannula (1149435)
Respironics Novametrix, LLC Sample Line-Female Luer Connector (3476-00)
Respironics Novametrix, LLC LoFlo CO2 Sampling Cannula ADULT ORAL/NASAL (3470ADU-00)
Respironics Novametrix, LLC LoFlo CO2 Sampling Cannula with Dehumidification Tubing ADULT NASAL (3468ADH-00)
Respironics Novametrix, LLC LoFlo CO2 Sampling Cannula (1149476)
Respironics Novametrix, LLC LoFlo CO2 Sampling Cannula (1149478)
Respironics Novametrix, LLC LoFlo CO2 Sampling Cannula INFANT/NEONATAL NASAL (3468INF-00)
Respironics Novametrix, LLC LoFlo Airway Adapter Kit INFANT/NEONATAL (3472INF-00)
KATENA PRODUCTS, INC
Respironics Novametrix, LLC AIRWAY, DEHUM TBG, ADU PED, SLM LOFLO 10 (3673ADU-00)
Respironics Novametrix, LLC CANNULA, NASAL/ORAL, CO2/O2 ADU, 704-0020-00 (3671ADU-00)
Respironics Novametrix, LLC AIRWAY, ADU-PED, SLM LOFLO (3672ADU-00)
Respironics Novametrix, LLC CANNULA, NASAL, CO2/O2 ADU, 704-0014-00 (3669ADU-00)
Respironics Novametrix, LLC CANNULA NASAL CO2 ADULT 704-0010-00 (3668ADU-00)
Respironics Novametrix, LLC SAMPLE LINE MALE LUER NAFION 704-0028-00 (3675-00)
Respironics Novametrix, LLC CANNULA NASAL/ORAL CO2 ADU 704-0017-00 (3670ADU-00)
Respironics Novametrix, LLC CANNULA NASAL CO2 PED 704-0012-00 (3668PED-00)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)