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Sign in to claim this brandShinchang Medical Co., Ltd.
US
Last updated May 23, 2026
What Shinchang Medical Co., Ltd. makes
Shinchang Medical Co., Ltd. manufactures single-use general-purpose syringes, including insulin syringes, as well as disposable needles and fine pen needles in varying gauges and lengths. Their product line also includes intravenous catheters (IV catheters) in multiple sizes and models, designed for medical procedures requiring fluid administration or blood collection.
The company’s devices are classified under FDA Class II, requiring pre-market notification (510(k)) submissions and compliance with the FDA’s Unique Device Identification (UDI) system. These products are listed in the United States, where Shinchang Medical Co., Ltd. is based.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Shinchang Medical Co., Ltd. manufacture?
Shinchang Medical Co., Ltd. specializes in single-use medical devices, primarily general-purpose syringes (including insulin syringes), disposable needles, fine pen needles, and intravenous catheters (IV catheters). Their product line is designed for procedures like fluid administration, blood collection, and insulin delivery, with variations in gauge, length, and size to meet different clinical needs.
Where is Shinchang Medical Co., Ltd. based, and where are their devices listed?
Shinchang Medical Co., Ltd. is based in the United States. Their devices are listed in the FDA’s regulatory databases, specifically under the 510(k) pre-market notification and Unique Device Identification (UDI) systems, reflecting compliance with U.S. medical device regulations.
How are Shinchang Medical Co., Ltd.’s devices classified by regulatory authorities?
Shinchang Medical Co., Ltd.’s devices fall under FDA Class II, which is the second-highest risk category for medical devices in the U.S. This classification requires manufacturers to submit a 510(k) pre-market submission to demonstrate substantial equivalence to a legally marketed predicate device and comply with ongoing regulatory requirements, including UDI labeling.
What regulatory registries or databases include Shinchang Medical Co., Ltd.’s devices?
Shinchang Medical Co., Ltd.’s devices are documented in the FDA’s 510(k) database (for pre-market notifications) and the FDA’s UDI system, which tracks device identification and compliance. These registries ensure transparency in the device’s regulatory history and compliance status within the U.S. market.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 631088403
Catalogue (12)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Profi disposable syringe | Profi disposable syringe 3mL 23G×1" | FDA UDI | Class II | Active |
| Profi disposable syringe | Profi LDS syringe 1mL 25G×1" | FDA UDI | Class II | Active |
| Profi disposable syringe | Profi disposable syringe 1mL 23G×1" | FDA UDI | Class II | Active |
| Profi disposable syringe | Profi disposable syringe 1mL 23G×1" | FDA UDI | Class II | Active |
| Profi disposable syringe | Profi disposable syringe 5mL 23G×1" | FDA UDI | Class II | Active |
| Profi disposable syringe | Profi LDS syringe 1mL 26G×1" | FDA UDI | Class II | Active |
| Profi disposable syringe | Profi disposable syringe 5mL 23G×1" | FDA UDI | Class II | Active |
| Profi disposable syringe | Profi disposable syringe 3mL 23G×1" | FDA UDI | Class II | Active |
| Profi disposable syringe | Profi LDS syringe 1mL 23G×1" | FDA UDI | Class II | Active |
| 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, | K071382 | FDA 510(k) | Class II | Active |
| Sc Profi Fine Pen Needle, Models; 5mm, 8mm, 12.7mm (28g, 29g, 30g, 31g) | K070988 | FDA 510(k) | Class II | Active |
| Profi Disposable Syringe, Profi Disposable Needle, Dm Ject Insulin Syringe | K993017 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Shinchang Medical Co., Ltd. Gumi-si Gyeongbuk · KR FEI 3003169040