Product
Our ProductHyuFIL, Synovial Fluid Substitute for Your Joints
“HyuFil” is a biomaterial medical device developed by Biot Korea Inc.,
which acquired a class IV license from the Ministry of Food and Drug Safety.
Characteristsics of HyuFIL
Colorless and transparent liquid form for injection (Luer Lock syringe)
Produced in a facility that guarantees Good Manufacturing Practices (GMP)
pH similar to the in vivo environment
Washes out the saline solution residue on the treatment area (e.g. knee or shoulder) and provides the correct viscosity for coating joint surfaces
Reduction of joints’ mechanical friction
* HyuFIL is a single-use disposable sterilized medical device; reuse or re-sterilization are prohibited.
Shape and Structure of HyuFIL
How HyuFIL Works
HyuFIL is to be injected into the joint cavity of the knee or shoulder to wash out the saline solution residue,
and to physically reduce the mechanical friction of joints by coating their surface,
temporarily compensating for lost joint synovial fluid.
The disposable syringe is composed of a barrel with a Luer Lock adapter, a plunder stopper, a plunger, and a tip cap.
Purpose of Use and Efficacy
To wash out the saline solution residue used during arthroscopic knee or shoulder treatment and surgery,
and to reduce physical friction by temporarily replacing lost joint synovial fluid.
Precautions for Use
1. Overall Precaution
- - HyuFIL is a sterilized product; it must maintain its sterile condition to avoid contamination when in use.
- - Ensure the packaging and sterilization are intact before applying the product; and you must fully inform the patient of the product’s indications, contraindications, and potential side effects.
2. Precaution Before Use
- - It should be used in an operating room where potential mistakes or side effects can be immediately dealt with.
- - The overall precautions for arthroscopic surgical procedures should be abided by before use.
Product Information
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Product Name (Model) & License Number
HyuFiL(BHF-230) / Jeheo No. 24-442
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Medical Device Type
Class IV biomaterial medical device for tissue repair (B04230.01(4))
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Producer Biot Korea Inc.
Unit 306-2B, Living Support Robot Center, Gwangju Technopark,
333, Cheomdangwagi-ro, Buk-gu, Gwangju, Republic of Korea -
Manufactory (GMP) Biot Korea Inc.
Unit 302, Living Support Robot Center, Gwangju Technopark,
333, Cheomdangwagi-ro, Buk-gu, Gwangju, Republic of Korea