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PDRN/PN Medical Grade
Quality Meet Mincoo's PDRN/PN factory
Product Attributes
Place of Origin
China
Brand Name
Mincoo
Certification
ISO9001, ISO13485
Product Code
PDRN-S-MS / PDRN-S-IS ; PN-S-MS / PN-S-IS
Product Description
Salmon derived

PDRN/PN Polydeoxynucleotide/Polynucleotide

PDRN Medical Grade is a high‑purity medical raw material refined from premium salmon milt DNA via a stable, validated manufacturing process.

Through gentle processing, the proteins, impurities, and allergens are removed as much as possible; it meets medical-grade safety standards for clinical and injectable applications.

With ultra‑high DNA homology with human skin tissue, salmon‑derived PDRN delivers excellent biocompatibility, low rejection risk, and stable bioactivity.

It accelerates tissue repair, relieves inflammation, promotes cell regeneration, and improves skin resilience, widely used in medical aesthetic injections, medical aesthetics, joint cavity repair, and clinical repair formulations.

Fully Enclosed Processing Medical Grade High Biocompatibility

PDRN/PN Medical Grade

PDRN/PN Medical Grade

Application

Wound healing and tissue repair (such as diabetic foot, burns). Potential applications in fields such as orthopedics, ophthalmology, and gynecology.

Skin repair, improvement of skin quality, anti-aging, and scar reduction. Widely used in medical beauty projects, such as water injection therapy, microneedling, skin revitalization products, and dermal fillers, etc.

Advantages

PDRN/PN Medical Grade

Natural source

Extracted from salmon milt, sustainably sourced from the certified FAO61 fishing zone.

PDRN/PN Medical Grade

Multi‑stage manufacturing process

Stable and gentle manufacturing process. Strict multi‑stage purification workflow.  

PDRN/PN Medical Grade

Precise enzymatic hydrolysis process

Accurate molecular weight control, supporting customization from 100~3500 kDa.

PDRN/PN Medical Grade

Hyperchromicity

Hyperchromicity is >40%, with a high content of double-stranded DNA.

PDRN/PN Medical Grade

Low bacterial endotoxins

Bacterial endotoxins are <0.05 EU/mg (with industry comparison benchmark).

Gel formation after sterilization

At a concentration of 1.5% aqueous solution, Medical Grade PDRN maintained a good gel state after moist‑heat sterilization at 121°C for 15 minutes.


PDRN/PN Medical Grade    Zero Toxicity

        No acute systemic toxicity observed.

PDRN/PN Medical Grade  Non‑Irritant

         Score 0.00 in irritation tests.

 PDRN/PN Medical Grade   Full Compliance

        Meets all medical device standards.

PDRN/PN Medical Grade

Safety Evaluation Reports


Test Item
Experimental Result
Conclusion
🌡️ Pyrogen Test
Total temperature rise of only 0.6°C.
✔ Pyrogen‑free
👤 Acute Systemic Toxicity
No deaths, toxic symptoms, or abnormal weight changes observed.
✔ No Toxicity
💉 Intracutaneous Reactivity
Final score of 0.00. No skin irritation response.
✔ Compliant
🤚 Skin Sensitization (GPMT)
The maximization test method showed 0% positive reaction rate.
✔ No Sensitization
⚓ Multiple Skin Irritation
14‑day repeated test showed a score of 0.00.
✔ No Irritation
🪶 Skin Sensitization (Buehler)
Buehler method showed 0% sensitization rate.
✔ No Allergy
📎 Cytotoxicity
L929 cell viability 82.25% (Grade 1). Excellent biocompatibility.
✔ Non‑cytotoxic
🖊️ Heavy Metals
Pb<0.03, Hg<0.001, As 0.0048, Cd<0.001 (mg/kg).
✔ Safe Limit
⚙️ Microbiological Test
Bacteria <10 CFU/g, Mold/Yeast <10 CFU/g, Pathogens: Absent.
✔ Hygienic



Medical Device Raw Material Master File


Mincoo’s Polydeoxyribonucleotide Master File has been registered with the Center for Medical Device Evaluation, NMPA.

The publicized information can be found on the Center for Medical Device Evaluation NMPA website. The website address is as follows: https://www.cmde.org.cn/xwdt/zwddjxxgs/20210413105900664.html

PDRN/PN Medical Grade
No. Master File Owner Master File Registration Item Name Master File Registration Number Registration/Update Date
1374 Shandong Mincoo Biotech Co., Ltd. Polydeoxyribonucleotide Raw Material Master File M2026155-000 2026/4/24