Mui Scientific
CanadaFDA applicant, unverified FDA FEI 3002807135
- Devices
- 5
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Mui Scientific makes
Mui Scientific manufactures motility catheters and specialized diagnostic tools for gastrointestinal studies, including the Rapid Barostat Bag (RBB) Pump and Catheter system, the Sphincter of Oddi Manometric (SOM) System, and pressurized infusion pumps. These devices are designed for measuring gastrointestinal motility, pressure, and sphincter function in clinical assessments.
The company’s portfolio consists of Class II medical devices, all of which are subject to FDA 510(k) clearance requirements. These products are listed under the FDA’s regulatory framework and are intended for use in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Motility Catheters Ref K823701
Regimes: 510(k) Registry: 510(k)Rapid Barostat Bag (RBB) Pump and Catheter Ref K160287
Regimes: 510(k) Registry: 510(k)Sphincter Of Oddi Manometric (Som) System Ref K120524
Regimes: 510(k) Registry: 510(k)Pressurized Infusion Pump Ref K122294
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3002807135
- Address
- 145 TRADERS BLVD. EAST, # 34, MISSISSAUGA Ontario
Frequently asked questions
How many devices does Mui Scientific have in the registry?
The registry currently lists 5 devices for Mui Scientific. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mui Scientific's devices?
Among its 5 most recently registered devices, Mui Scientific has devices listed in FDA 510(k) (5 devices).
What risk classes do Mui Scientific's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Mui Scientific's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Mui Scientific in the registry?
The most recently registered devices listed for Mui Scientific include Rapid Barostat Bag (RBB) Pump and Catheter System, MOTILITY CATHETERS, Rapid Barostat Bag (RBB) Pump and Catheter and SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM.