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Sign in to claim this brandTSK LABORATORY, JAPAN
US
Last updated May 24, 2026
What TSK LABORATORY, JAPAN makes
TSK Laboratory manufactures single-use hypodermic needles and tissue injection cannulas, including sterile disposable options designed for medical procedures. Their portfolio includes cannulas for subcutaneous or intramuscular injections, as well as hypodermic needles for general use in clinical settings. Examples include sterile injection cannulas and hypodermic needles marketed under specific product names like STERiJECT™ and STERiGLIDE™.
The company’s devices are classified under FDA regulations as either Class I or Class II, with all products listed in the FDA’s Unique Device Identifier (UDI) database. These products are intended for use in the United States, where TSK Laboratory 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 TSK Laboratory manufacture?
TSK Laboratory specializes in single-use medical devices, specifically hypodermic needles and tissue injection cannulas. These products are designed for clinical procedures, including subcutaneous or intramuscular injections. Examples include sterile disposable cannulas and hypodermic needles, such as those branded STERiJECT™ and STERiGLIDE™.
Where is TSK Laboratory based, and where are its devices primarily intended for use?
TSK Laboratory is based in the United States, though it originates from Japan. The company’s devices are manufactured and intended for use in the US market, where they are subject to FDA regulations.
Which regulatory registries list TSK Laboratory’s devices?
TSK Laboratory’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance tracking for medical devices authorized for use in the United States.
How are TSK Laboratory’s devices classified under FDA regulations?
TSK Laboratory’s devices fall under two FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and require less regulatory oversight, while Class II devices involve moderate risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential risks.
Why are some of TSK Laboratory’s devices listed as Class II?
TSK Laboratory’s Class II devices are categorized as such because they involve a higher level of risk compared to Class I products. For example, tissue injection cannulas may carry a slightly greater risk of complications (e.g., tissue damage or infection) than basic hypodermic needles, necessitating additional regulatory scrutiny to ensure proper design, manufacturing, and performance controls.
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
- 716217877
Catalogue (252)
Page 1 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Csh Cannula | CSH-22050 | FDA UDI | Class I | Active |
| STERiJECT TM | LDS-33013 | FDA UDI | Class II | Active |
| Csh Cannula | CSH-27038 | FDA UDI | Class I | Active |
| STERiJECT TM | PRC22070ICSH | FDA UDI | Class II | Active |
| Csh Cannula | CSH-27050 | FDA UDI | Class I | Active |
| Csh Cannula | CSH-22070 | FDA UDI | Class I | Active |
| STERiJECT TM | HPC-23013I | FDA UDI | Class II | Active |
| STERiGLIDE TM | SGC-25050 | FDA UDI | Class I | Active |
| Csh Cannula | CSH-21050 | FDA UDI | Class I | Active |
| STERiJECT TM | PRC25050ICSH | FDA UDI | Class II | Active |
| STERiJECT TM | HPC-31013E | FDA UDI | Class II | Active |
| STERiJECT TM | HPC-32013A | FDA UDI | Class II | Active |
| STERiJECT TM | HPC-31013E | FDA UDI | Class II | Active |
| STERiJECT TM | HPC-29010E | FDA UDI | Class II | Active |
| Csh Cannula | CSH-25050 | FDA UDI | Class I | Active |
| Csh Cannula | CSH-27025 | FDA UDI | Class I | Active |
| STERiJECT TM | HPC-29010E | FDA UDI | Class II | Active |
| Csh Cannula | CSH-27070 | FDA UDI | Class I | Active |
| Csh Cannula | CSH-22038 | FDA UDI | Class I | Active |
| STERiGLIDE TM | SGC-070050A | FDA UDI | Class I | Active |
| STERiJECT TM | HPC-30013E | FDA UDI | Class II | Active |
| STERiGLIDE TM | SGC-070070A | FDA UDI | Class I | Active |
| STERiJECT TM | PRC22038ICSH | FDA UDI | Class II | Active |
| Csh Cannula | CSH-27038 | FDA UDI | Class I | Active |
| STERiGLIDE TM | SGC-22070 | FDA UDI | Class I | Active |
| STERiJECT TM | PRC-30013I | FDA UDI | Class II | Active |
| STERiGLIDE TM | SGC-25050 | FDA UDI | Class I | Active |
| STERiJECT TM | PRE-30004 | FDA UDI | Class II | Active |
| STERiGLIDE TM | SGC-070050A | FDA UDI | Class I | Active |
| STERiJECT TM | LDS-30009I | FDA UDI | Class II | Active |
| STERiGLIDE TM | SGA-050038A | FDA UDI | Class I | Active |
| Csh Cannula | CSH-22070 | FDA UDI | Class I | Active |
| STERiJECT TM | PRC-25013I | FDA UDI | Class II | Active |
| Csh Cannula | CSH-30025 | FDA UDI | Class I | Active |
| STERiJECT TM | PRC-25038ISG | FDA UDI | Class II | Active |
| STERiGLIDE TM | SGC-040038A | FDA UDI | Class I | Active |
| Csh Cannula | CSH-25038 | FDA UDI | Class I | Active |
| STERiJECT TM | PRE-32013N | FDA UDI | Class II | Active |
| STERiJECT TM | PRE-27013IP | FDA UDI | Class II | Active |
| Csh Cannula | CSH-25070 | FDA UDI | Class I | Active |
| STERiJECT TM | HPC-30013E | FDA UDI | Class II | Active |
| STERiGLIDE TM | SGC-30025 | FDA UDI | Class I | Active |
| STERiGLIDE TM | SGC-25038 | FDA UDI | Class I | Active |
| STERiJECT TM | LDS-02009 | FDA UDI | Class II | Active |
| Csh Cannula | CSH-30019 | FDA UDI | Class I | Active |
| STERiJECT TM | LDS-27006I | FDA UDI | Class II | Active |
| Csh Cannula | CSH-25025 | FDA UDI | Class I | Active |
| Csh Cannula | CSH-22025 | FDA UDI | Class I | Active |
| STERiJECT TM | LDS-30013I | FDA UDI | Class II | Active |
| STERiGLIDE TM | SGC-27050 | FDA UDI | Class I | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Tsk Laboratory, Japan TOCHIGI-SHI · JP FEI 3012854006