Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000484830

FEI Number

1000484830

Entity Name

Polimeros Formula de Tecate S.A de C.V

City/State/Country

Tecate Baja California, MX

Establishment Address

Guaycura No. 106, Col. El Paraiso, Tecate Baja California 21485, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Polimeros Formula de Tecate, SA de CV (Owner Number: 10054378)

Owner / Operator Contact Address

Guaycura No. 106, Col. El Paraiso, Tecate, MX-BCN 21485, MX

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2026-05-07
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2021-09-27
QEF	Pressure Ulcer Management Tool	Gastroenterology, Urology	Class 1	876.2100	2024-07-15
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2026-03-03
KDT	Container, Specimen Mailer And Storage, Sterile	Pathology	Class 1	864.3250	2022-11-01
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2020-02-13
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2026-03-03
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2025-07-09
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2026-03-02
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2022-10-28
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2025-11-26
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2022-11-03
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2026-05-07
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2025-12-16
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2026-04-30
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-07-09
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-02-17

Official Correspondent

Alejandro Mendez

US Agent Details

Bill Gerard Business: Formula Plastics Inc Email: regulatory@formulaplastics.com Phone: (480) 3445000

Related Public Records

Same Entity

Polimeros Formula de Tecate, SA de CV

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12
K171373	3M Company	3M Bair Hugger Model 675 Total Temperature Management System	2017-10-10
K083336	Smiths Medical Asd, Inc.	LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL	2009-06-03
K811059	Pentax Precision Instrument Corp.	PENTAX BRONCHOFIBERSCOPE #FB-15A	1981-05-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000484830. Last updated year: 2026. Please use registration number 1000484830 when referencing this establishment in official correspondence.