Regu-Tech Assoc., Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Regu-Tech Assoc., Inc. makes
Regu-Tech Assoc., Inc. manufactures oral health and feminine hygiene products, including silicone teething toys for infants and cotton-based tampons designed for menstrual care.
Their portfolio consists of Class II medical devices, all of which are cleared via the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Tyco Baby Sesame Street Soft Teether Ref K963912
Regimes: 510(k) Registry: 510(k)Femtex 100% Cotton Dentle Touch Tampons Ref K970232
Regimes: 510(k) Registry: 510(k)Femtex 100% Cotton Tampons Ref K971228
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Regu-Tech Assoc., Inc. have in the registry?
The registry currently lists 3 devices for Regu-Tech Assoc., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Regu-Tech Assoc., Inc.'s devices?
Among its 3 most recently registered devices, Regu-Tech Assoc., Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Regu-Tech Assoc., Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Regu-Tech Assoc., Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Regu-Tech Assoc., Inc. in the registry?
The most recently registered devices listed for Regu-Tech Assoc., Inc. include TYCO BABY SESAME STREET SOFT TEETHER, FEMTEX 100% COTTON DENTLE TOUCH TAMPONS and FEMTEX 100% COTTON TAMPONS.