Data / Medical devices / South Korea / Shinchang Medical Co., Ltd.
Shinchang Medical Co., Ltd.: FDA-registered device maker in Gumi-si Gyeongbuk, South Korea, 3 510(k) clearances
Shinchang Medical Co., Ltd. is registered with the FDA (registration 9616157) in Gumi-si Gyeongbuk, South Korea. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 16, 2007. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9616157
- FEI number
- 3003169040
- Address
- 144, 1gongdan-ro 6-gil, Gumi-si Gyeongbuk, South Korea, 39385
- Owner or operator
- SHIN CHANG MEDICAL CO., LTD. (9035332)
- Roles
- Manufacturer
- First device listed
- October 17, 2007
- Registered through
- 2027
- Brand names listed
- DMject Insulin Syringe, Profi Needle, Profi Pen Needle, Profi Syringe, SCM IV Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | 2 | Manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| October 16, 2007 | K071382 | SCM CATH ( SIZES ARE VARYING BETWEEN 16G X 2'' AND 24G X 3/4'' ), MODEL 1.50, 1.77,1.88',2, 1.25, 1.50, 1.77, | FOZ | Substantially Equivalent | Shinchang Medical Co., Ltd. | accessdata.fda.gov |
| August 23, 2007 | K070988 | SC PROFI FINE PEN NEEDLE, MODELS; 5MM, 8MM, 12.7MM (28G, 29G, 30G, 31G) | FMI | Substantially Equivalent | Shinchang Medical Co., Ltd. | accessdata.fda.gov |
| February 25, 2000 | K993017 | PROFI DISPOSABLE SYRINGE, PROFI DISPOSABLE NEEDLE, DM JECT INSULIN SYRINGE | FMF | Substantially Equivalent | Shinchang Medical Co., Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 24, 2018 | 80944 | Class II | Terminated | Disposable Insulin Syringe 0.3mL in 3 different sizes 29Gx1/2, 30Gx5/16, and 31G x 5/16. (10 syringes are packaged in a flexible plastic (poly bag) and 10 flexible plastic (poly bag) are packaged in one in box. Finally, | Defect consists of a small crack in the top end of the barrel near the needle. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- All makers of Syringe, Piston
- All makers of Needle, Hypodermic, Single Lumen
Updated October 16, 2007. 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.