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Sign in to claim this brandCOHO BIOMEDICAL TECHNOLOGY CO., LTD.
US
Last updated May 23, 2026
What COHO BIOMEDICAL TECHNOLOGY CO., LTD. makes
Coho Biomedical Technology manufactures dental implant systems, including components like abutment impression caps and torque wrenches, alongside reusable dental tools such as drill bits, scalpel blades, and handles. Their portfolio also includes ceramic materials for dental appliance fabrication and implant abutment screw analogs designed for prosthetic fitting. The company produces both single-use and reusable instruments tailored for dental implantology and restorative procedures.
The company’s devices are regulated under FDA’s classification system, with products falling into Class I and Class II categories. These items are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. medical device regulations. The manufacturer operates from the United States.
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 Coho Biomedical Technology Co., Ltd. primarily manufacture?
Coho Biomedical Technology Co., Ltd. specializes in dental devices, including implant systems like abutment impression caps and torque wrenches. Their portfolio also covers reusable tools such as drill bits, scalpel blades, handles, and ceramic materials for dental appliance fabrication. These products support dental implantology and restorative procedures, addressing both single-use and reusable instrument needs.
Where is Coho Biomedical Technology Co., Ltd. based, and how does this affect its regulatory compliance?
Coho Biomedical Technology Co., Ltd. is based in the United States, which means its devices are subject to FDA regulations. The company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring compliance with U.S. requirements for traceability and transparency in the medical device supply chain.
Which regulatory registries or databases list Coho Biomedical Technology Co., Ltd.’s devices?
Coho Biomedical Technology Co., Ltd.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and verify the identity of medical devices, ensuring proper classification and compliance with U.S. regulatory standards.
How are Coho Biomedical Technology Co., Ltd.’s devices classified under FDA regulations?
Coho Biomedical Technology Co., Ltd.’s devices fall into 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 require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential health impact.
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
- 658658526
Catalogue (92)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Zibone | Me-M3647 | FDA UDI | Class I | Active |
| Zibone | Zr-P2017 | FDA UDI | Class I | Active |
| Zibone | Zr-D4316 | FDA UDI | Class I | Active |
| Zibone | Zr-I5008 | FDA UDI | Class II | Active |
| Z-40 | Z-6510 | FDA UDI | Class II | Active |
| Zibone | Zr-B9820 | FDA UDI | Class II | Active |
| Zibone | Zr-B9814 | FDA UDI | Class II | Active |
| Z-40 | Z-5214 | FDA UDI | Class II | Active |
| Zibone | SP-3610 | FDA UDI | Class I | Active |
| Zibone | Zr-I4011 | FDA UDI | Class II | Active |
| Z-40 | Z-4508 | FDA UDI | Class II | Active |
| Z-40 | Z-3710 | FDA UDI | Class II | Active |
| Zibone | CST-B15 | FDA UDI | Class I | Active |
| Zibone | Zr-C9816-A2 | FDA UDI | Class II | Active |
| Zibone | CST-B63 | FDA UDI | Class I | Active |
| Z-40 | Z-4516 | FDA UDI | Class II | Active |
| Zibone | Zr-B9818 | FDA UDI | Class II | Active |
| Z-40 | Z-7510 | FDA UDI | Class II | Active |
| Z-40 | Z-6511 | FDA UDI | Class II | Active |
| Zibone | Pk-H3665 | FDA UDI | Class I | Unknown |
| Zibone | CST-B15C | FDA UDI | Class I | Active |
| Zibone | Me-M3640 | FDA UDI | Class I | Unknown |
| Zibone | Zr-D3416 | FDA UDI | Class I | Active |
| Zibone | IP-4004 | FDA UDI | Class I | Active |
| Z-40 | Z-3708 | FDA UDI | Class II | Active |
| Z-40 | Z-6514 | FDA UDI | Class II | Active |
| Zibone | Zr-I4013 | FDA UDI | Class II | Active |
| Zibone | Me-A4815 | FDA UDI | Class I | Active |
| Zibone | Zr-I4014 | FDA UDI | Class II | Active |
| Zibone | Zr-I3613 | FDA UDI | Class II | Active |
| Z-40 | Z-5210 | FDA UDI | Class II | Active |
| Zibone | Zr-G2316 | FDA UDI | Class I | Active |
| Zibone | CST-H04 | FDA UDI | Class I | Active |
| Zibone | Zr-D3816 | FDA UDI | Class I | Active |
| Zibone | CST-B65 | FDA UDI | Class I | Active |
| Zircasso | ZCS-I5112 | FDA UDI | Class II | Active |
| Zibone | Zr-D2816 | FDA UDI | Class I | Active |
| Z-40 | Z-7508 | FDA UDI | Class II | Active |
| Zibone | CST-H06 | FDA UDI | Class I | Active |
| Zibone | Zr-C9812-A3 | FDA UDI | Class II | Active |
| Zircasso | ZCS-I4114 | FDA UDI | Class II | Active |
| Zibone | Zr-I3614 | FDA UDI | Class II | Active |
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