International Regulatory Consultants
Country not established
- Devices
- 6
What International Regulatory Consultants makes
International Regulatory Consultants manufactures single-use medical devices, including ureteral stents (Vortek and Biosoft double loop), disposable syringes and needles (DispoMedic and Shifa brands), and a baby thermometer (Memotherm 10). Their product line also covers wound care solutions, such as MEDISURF.
The company’s devices are regulated under FDA 510(k) clearance requirements, with products classified as Class I and Class II. These devices are listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
Medisurf Ref K971347
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Dispomedic Disposable Syringes And Needles Ref K950012
Regimes: 510(k) Registry: 510(k)Digital Thermometer; Digital Thermometer Ref K102718
Regimes: 510(k) Registry: 510(k)Shifa Sterile Disposable Syringes Ref K962614
Regimes: 510(k) Registry: 510(k)Memotherm 10 Baby Thermometer Ref K935280
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does International Regulatory Consultants have in the registry?
The registry currently lists 6 devices for International Regulatory Consultants. Devices recorded under merged duplicate company entries are counted once.
Which registries list International Regulatory Consultants's devices?
Among its 6 most recently registered devices, International Regulatory Consultants has devices listed in FDA 510(k) (6 devices).
What risk classes do International Regulatory Consultants's devices fall under?
Among its 6 most recently registered devices, the classes recorded for International Regulatory Consultants's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from International Regulatory Consultants in the registry?
The most recently registered devices listed for International Regulatory Consultants include MEDISURF, VORTEK URETERAL DOUBLE LOOP STENT, BIOSOFT URETERAL DOUBLE LOOP STENT, DISPOMEDIC DISPOSABLE SYRINGES AND NEEDLES and DIGITAL THERMOMETER; DIGITAL THERMOMETER.