Sofilm Technology Co., Ltd.
TaiwanFDA applicant, unverified
- Devices
- 1
What Sofilm Technology Co., Ltd. makes
Sofilm Technology Co., Ltd. manufactures the CARLO Surgical Gown, a single-use protective garment designed for surgical procedures to maintain sterile field integrity and reduce contamination risk during operations.
The CARLO Surgical Gown is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Carlo Surgical Gown Ref K051426
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sofilm Technology Co., Ltd. have in the registry?
The registry currently lists 1 device for Sofilm Technology Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sofilm Technology Co., Ltd.'s devices?
Among its 1 most recently registered device, Sofilm Technology Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Sofilm Technology Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Sofilm Technology Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sofilm Technology Co., Ltd. in the registry?
The most recently registered devices listed for Sofilm Technology Co., Ltd. include CARLO SURGICAL GOWN.