Data / Medical devices / South Korea / Sprinkle Co., Ltd.
Sprinkle Co., Ltd.: FDA-registered device maker in Yongin Gyeonggi, South Korea, 1 510(k) clearance
Sprinkle Co., Ltd. is registered with the FDA (registration 3008951115) in Yongin Gyeonggi, South Korea. It lists 14 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 5, 2013. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3008951115
- Address
- #12-18 Hanil-ro, Giheung, Yongin Gyeonggi, South Korea, 17099
- Owner or operator
- Sprinkle Co., Ltd. (10035316)
- Roles
- Exporter to the US, Remanufacturer
- First device listed
- February 18, 2011
- Registered through
- 2026
- Brand names listed
- Pure-Aid, Sure-aid
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bandage, Elastic | FQM | 1 | Exporter to the US | accessdata.fda.gov |
| Disinfectant, Medical Devices | LRJ | 1 | Exporter to the US | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Exporter to the US | accessdata.fda.gov |
| Fiber, Medical, Absorbent | FRL | 1 | Exporter to the US | accessdata.fda.gov |
| Floss, Dental | JES | 1 | Exporter to the US | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Exporter to the US | accessdata.fda.gov |
| Joint, Ankle, External Brace | ITW | 1 | Exporter to the US | accessdata.fda.gov |
| Joint, Knee, External Brace | ITQ | 1 | Exporter to the US | accessdata.fda.gov |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | 2 | Exporter to the US | accessdata.fda.gov |
| Pack, Hot Or Cold, Disposable | IMD | 1 | Exporter to the US | accessdata.fda.gov |
| Pad, Alcohol, Device Disinfectant | LKB | U | Exporter to the US | accessdata.fda.gov |
| Pad, Menstrual, Unscented | HHD | 1 | Exporter to the US | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Remanufacturer | accessdata.fda.gov |
| Visual, Pregnancy Hcg, Prescription Use | JHI | 2 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 5, 2013 | K123050 | EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II) | LCX | Substantially Equivalent | Nantong Biotechnology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Fiber, Medical, Absorbent
- All makers of Pad, Menstrual, Unscented
- All makers of Pack, Hot Or Cold, Disposable
- All makers of Joint, Knee, External Brace
- All makers of Joint, Ankle, External Brace
- All makers of Gauze / Sponge,Nonresorbable For External Use
Updated February 5, 2013. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.