Anexa Biomedical, Inc.
U.S.-based manufacturer of personal protective equipment (PPE) and sterile irrigation fluids. Operates a domestic manufacturing facility producing surgical masks, N95 filtering respirators, face shields, powered air-purifying respirator (PAPR) assemblies, and USP sterile saline/sterile water. Offers private-label and contract manufacturing, in-house production engineering and automation, aseptic filling, and domestic sourcing. Holds ISO 13485:2016 certification and is an FDA-registered device facility.
Industries
N/A
Nr. of Employees
small (1-50)
Anexa Biomedical, Inc.
7201 Iron Horse Blvd., North Richland Hills, TX 76180
Patents
Products
Surgical masks (ASTM Level 1–3)
Single-use surgical masks available in multiple fluid-resistance levels and styles (earloop, tie-on, duckbill, anti-fog variants, pediatric sizes).
N95 filtering respirators cleared for surgical use
N95 respirators manufactured to recognized filtration and certification standards, offered in multiple styles and comfort variants for clinical use.
Face shields and eye protection
Optically clear, anti-fog face shields in multiple lengths and styles for splash and spray protection in clinical and industrial settings.
Sterile normal saline and sterile water (USP irrigation solutions)
USP sterile 0.9% sodium chloride and sterile water packaged in multiple container formats (100 mL–1000 mL screw-top bottles and foil-lidded cups) for irrigation and wound care (not for injection).
Surgical masks (ASTM Level 1–3)
Single-use surgical masks available in multiple fluid-resistance levels and styles (earloop, tie-on, duckbill, anti-fog variants, pediatric sizes).
N95 filtering respirators cleared for surgical use
N95 respirators manufactured to recognized filtration and certification standards, offered in multiple styles and comfort variants for clinical use.
Face shields and eye protection
Optically clear, anti-fog face shields in multiple lengths and styles for splash and spray protection in clinical and industrial settings.
Sterile normal saline and sterile water (USP irrigation solutions)
USP sterile 0.9% sodium chloride and sterile water packaged in multiple container formats (100 mL–1000 mL screw-top bottles and foil-lidded cups) for irrigation and wound care (not for injection).
Services
On-site contract production and private-label manufacturing of flat-form medical products made from non-woven fabrics, films, elastics and tapes; services include product development, tooling, and automated production.
On-site assembly, kitting, and manufacturing support for powered air-purifying respirator systems and related accessories.
On-site contract production and private-label manufacturing of flat-form medical products made from non-woven fabrics, films, elastics and tapes; services include product development, tooling, and automated production.
On-site assembly, kitting, and manufacturing support for powered air-purifying respirator systems and related accessories.
Expertise Areas
- Respiratory protection manufacturing
- Sterile irrigation fluid production and aseptic filling
- Regulatory-compliant medical device quality systems (ISO 13485, FDA)
- Contract and private-label manufacturing for non-woven medical products
Key Technologies
- Non-woven fabric conversion and assembly
- Aseptic filling and sterile packaging for irrigation fluids
- High-speed rotary manufacturing
- Laminating, ultrasonic bonding and radio-frequency bonding
News & Updates
Acquisition expanded offerings to include domestic sterile water and sterile saline production; Anexa production equipment was relocated to the company's North Richland Hills facility.
Premier Inc. and 15 health systems acquired a minority stake and committed multi-year purchases to expand domestic PPE production capacity.
Announcement of FDA clearance for a surgical mask product incorporating an active antiviral surface treatment and availability for U.S. healthcare markets.
Archived articles and press coverage highlighting domestic mask manufacturing, facility openings, facility purchase and pandemic preparedness efforts.
Maintains ISO 13485:2016 certification and operates as an FDA-registered medical device facility.
Certified as a Historically Underutilized Business by the State of Texas (certificate approval date 2022-03-18).
Acquisition expanded offerings to include domestic sterile water and sterile saline production; Anexa production equipment was relocated to the company's North Richland Hills facility.
Premier Inc. and 15 health systems acquired a minority stake and committed multi-year purchases to expand domestic PPE production capacity.
Announcement of FDA clearance for a surgical mask product incorporating an active antiviral surface treatment and availability for U.S. healthcare markets.
Archived articles and press coverage highlighting domestic mask manufacturing, facility openings, facility purchase and pandemic preparedness efforts.
Maintains ISO 13485:2016 certification and operates as an FDA-registered medical device facility.
Certified as a Historically Underutilized Business by the State of Texas (certificate approval date 2022-03-18).