Sung Shim Medicare Co., Ltd.
South KoreaFDA applicant, unverified FDA
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Sung Shim Medicare Co., Ltd. makes
Sung Shim Medicare Co., Ltd. manufactures sterile, single-use insulin syringes and insulin pen needles designed for diabetes management. These products are intended for subcutaneous administration of insulin and are packaged for one-time use to ensure sterility and safety.
The company’s portfolio is regulated under FDA Class II devices and is listed via 510(k) clearance in the United States. The products are intended for distribution and use within the US market.
Catalogue
Sungshim Sterile Single Use Insulin Syringe Ref K152803
Regimes: 510(k) Registry: 510(k)Sungshim Insulin Pen Needle Ref K152334
Regimes: 510(k) Registry: 510(k)
FDA establishments
- Sungshim Medicare Co., Ltd. Anseong-si Gyeonggi · KR FEI 3013160284
Frequently asked questions
How many devices does Sung Shim Medicare Co., Ltd. have in the registry?
The registry currently lists 2 devices for Sung Shim Medicare Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sung Shim Medicare Co., Ltd.'s devices?
Among its 2 most recently registered devices, Sung Shim Medicare Co., Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Sung Shim Medicare Co., Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Sung Shim Medicare Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sung Shim Medicare Co., Ltd. in the registry?
The most recently registered devices listed for Sung Shim Medicare Co., Ltd. include SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE and Sungshim Insulin Pen Needle.
Which FDA establishments are linked to Sung Shim Medicare Co., Ltd.?
1 FDA establishment is linked to Sung Shim Medicare Co., Ltd. in the registry; they are listed on the company page.