Sincere Medical Device Co., Ltd.
TaiwanFDA applicant, unverified
- Devices
- 2
What Sincere Medical Device Co., Ltd. makes
Sincere Medical Device Co., Ltd. manufactures prefilled insulin syringes and safety syringes, including variants with and without needles. These devices are designed for single-use injections, incorporating features to reduce needle-stick injuries and improve user safety during administration.
The company’s products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. These devices are intended for distribution in the United States, where compliance with FDA requirements is mandatory.
Catalogue
3S Safety Insulin Syringe Ref K142436
Regimes: 510(k) Registry: 510(k)3S Safety Syringe with/without Needle Ref K142435
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sincere Medical Device Co., Ltd. have in the registry?
The registry currently lists 2 devices for Sincere Medical Device Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sincere Medical Device Co., Ltd.'s devices?
Among its 2 most recently registered devices, Sincere Medical Device Co., Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Sincere Medical Device Co., Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Sincere Medical Device Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sincere Medical Device Co., Ltd. in the registry?
The most recently registered devices listed for Sincere Medical Device Co., Ltd. include 3S Safety Insulin Syringe and 3S Safety Syringe with/without Needle.