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Sign in to claim this brandNEXONE BIO CO., LTD.
US
Last updated May 25, 2026
What NEXONE BIO CO., LTD. makes
Nexone Bio Co., Ltd. manufactures bone access cannulas, specifically the CAPO Needle, designed for precise insertion into bone tissue. These devices are intended for procedures requiring controlled access to bone, such as orthopedic interventions or bone marrow aspiration.
The CAPO Needle is classified as a Class I medical device under regulatory frameworks and is listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in 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 Nexone Bio Co., Ltd. manufacture?
Nexone Bio Co., Ltd. specializes in bone access cannulas, specifically the CAPO Needle. These devices are engineered for precise insertion into bone tissue, commonly used in orthopedic procedures or bone marrow aspiration where controlled access is required.
Where is Nexone Bio Co., Ltd. based?
Nexone Bio Co., Ltd. is headquartered in the United States. The company’s location is relevant for regulatory compliance and device distribution within the region.
Which regulatory registries list devices manufactured by Nexone Bio Co., Ltd.?
The CAPO Needle, produced by Nexone Bio Co., Ltd., is listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices for regulatory and market surveillance purposes.
How are devices from Nexone Bio Co., Ltd. classified under regulatory standards?
The CAPO Needle, the primary device produced by Nexone Bio Co., Ltd., falls under the classification of Class I medical devices. This classification is typically assigned to devices posing minimal risk, often requiring less stringent regulatory oversight.
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
- 693705461
Catalogue (5)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| CAPO Needle | NOB-VPU11D | FDA UDI | Class I | Active |
| CAPO Needle | NOR-OSK095D | FDA UDI | Class I | Active |
| CAPO Needle | NOB-VPU11SB | FDA UDI | Class I | Active |
| CAPO Needle | NOB-VPNL10D | FDA UDI | Class I | Active |
| CAPO Needle | NOR-VPNL11SB | FDA UDI | Class I | Active |
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