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[Production License Number] Sujiang Medical Device Production License No. 20240191
[Product Registration Certificate Number] Su Medical Device Registration No. 20252201895
[Product Technical Requirements Number] Su Medical Device Registration No. 20252201895
[Product Name] Single-use sterile dermaroller
【Model Specifications】
| I: 0.2 × 0.2 – (3 to 9) |
I: 0.23 × 2.5 − (3 to 9) |
I: 0.3 × 1.0 – (3–9) |
II: 0.2 × 0.2 – (3 to 9) |
| I: 0.2 × 0.3 − (3 to 9) |
I: 0.23 × 3.0 − (3–9) |
I: 0.3 × 1.5 − (3 to 9) |
II: 0.2 × 0.25 – (3 to 9) |
| I: 0.2 × 0.5 − (3 to 9) |
I: 0.25 × 0.2 − (3 to 9) |
I: 0.3 × 2.0 − (3–9) |
II: 0.2 × 0.3 − (3 to 9) |
| I: 0.2 × 1.0 – (3–9) |
I: 0.25 × 0.3 − (3 to 9) |
I: 0.3 × 2.5 − (3 to 9) |
II: 0.2 × 0.5 – (3 to 9) |
| I: 0.2 × 1.5 − (3 to 9) |
I: 0.25 × 0.5 − (3 to 9) |
I: 0.3 × 3.0 − (3 to 9) |
II: 0.2 × 1.0 – (3–9) |
| I: 0.2 × 2.0 − (3 to 9) |
I: 0.25 × 1.0 – (3–9) |
I: 0.36 × 0.2 − (3 to 9) |
II: 0.2 × 1.5 − (3–9) |
| I: 0.2 × 2.5 − (3 to 9) |
I: 0.25 × 1.5 − (3 to 9) |
I: 0.36 × 0.3 − (3 to 9) |
|
| I: 0.2 × 3.0 − (3–9) |
I: 0.25 × 2.0 − (3–9) |
I: 0.36 × 0.5 − (3 to 9) |
|
| I: 0.23 × 0.2 − (3 to 9) |
I: 0.25 × 2.5 − (3 to 9) |
I: 0.36 × 1.0 – (3–9) |
|
| I: 0.23 × 0.3 − (3 to 9) |
I: 0.25 × 3.0 − (3–9) |
I: 0.36 × 1.5 − (3 to 9) |
|
| I: 0.23 × 0.5 − (3 to 9) |
I: 0.3 × 0.2 − (3 to 9) |
I: 0.36 × 2.0 − (3–9) |
|
| I: 0.23 × 1.0 − (3–9) |
I: 0.3 × 0.3 – (3 to 9) |
I: 0.36 × 2.5 − (3 to 9) |
|
| I: 0.23 × 1.5 − (3 to 9) |
I: 0.3 × 0.5 − (3 to 9) |
I: 0.36 × 3.0 − (3–9) |
|
| I: 0.23 × 2.0 − (3–9) |
|
|
|
【Structural Composition】
The single-use sterile dermaroller is available in two models: Type I and Type II. Type I consists of a handle, a support frame, solid needles, clamping clips, roller discs, and a protective cover; Type II comprises a handle, a support frame, a shaft, roller discs, needle plates, clamping clips, and a protective cover. This product is supplied in a sterile condition, sterilized with ethylene oxide, and intended for single use only.
【Material】
1) The needle and needle plate are made of 06Cr19Ni10N austenitic stainless steel.
2) The handle, bracket, shaft, roller blade, and roller are made of medical-grade polycarbonate.
【Main Performance Parameters】
1) Hardness: The hardness of the needle on the roller needle shall be not less than 460 HV0.2.
2) Firmness: During the firmness test, the needles arranged on the roller disc shall show no signs of loosening, breakage, or detachment.
【Scope of Application】
Rolling needle therapy is performed for localized stimulation of specific areas on the body surface.
[Installation and Usage Instructions or Diagrams]
1) Preparatory steps: First, cleanse and disinfect the skin with medical alcohol or saline solution, ensuring the skin remains dry.
2) Before use, ensure that the product packaging is intact and that the model and specifications meet the requirements.
3) During use, tear open the package at the opening, remove the needle roller, and inspect its appearance and integrity.
4) Confirm the treatment area, then gently roll the single-use dermaroller over the skin (Note: Do not apply excessive pressure, pull sharply up and down, or repeatedly roll over the same area, to avoid skin damage or inflammation).
5) After completing the rolling procedure, discard the needle and properly dispose of the waste to prevent cross-contamination.
6) Post-treatment care: Clean the skin with medical alcohol or saline solution to prevent cross-contamination.
Keywords:
Single-use Sterile Dermaroller (Type I)
Single-use Sterile Dermaroller (Type I)
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Jiangsu Kebang Bioscience Co., Ltd.
Address: Yangzhou Health and Medical Industry Park, Touqiao Town, Guangling District, Yangzhou City