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Capability

FDA registered facility

Suppliers
2
States & provinces
2
Countries
1

2 fda registered facility suppliers across 2 states and provinces in 1 country. Profiles show capabilities, materials, certifications, and facility locations so you can compare shops and build a shortlist.

Suppliers

FACTOR II INC

LAKESIDE, AZ

Factor II has supplied medical, prosthetic, and special effects professionals with professional-grade silicone elastomers, adhesives, and specialty materials since 1978. The company offers technical support and maintains an FDA-registered facility, with USP Class VI biocompatibility testing and COAs/COCs available for all lot numbers.

silicone formulationtechnical supportUSP Class VI biocompatibility testing

Compiled from public sources

INFINEUM MEDICAL

LARGO, FL

Infinium Medical, Inc. is a USA manufacturer of patient monitoring systems and critical care equipment, headquartered in Largo, Florida. Its monitors are manufactured at an FDA registered, ISO 13485 certified facility, and the Omni and Cleo lines carry EU MDR and CE certification. The company supplies medical equipment for outpatient centers, hospitals, and clinics, with 500+ equipment SKUs and distribution to 87 countries.

after-sales and warranty servicecentral station network monitoringHL7 compliant connectivityISO 13485 certified manufacturingmedical device manufacturingparts and repairs

Compiled from public sources

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