Complete Regulatory Documentation and Intellectual Property Portfolio
Yanhua Bio holds comprehensive medical device licenses, production certifications, and core invention patents for extracellular vesicle and cytokine technology. All qualifications are verified and available for institutional review.
Intellectual Property at a Glance
Medical Device Licenses and Certifications
Yanhua Bio holds complete regulatory documentation for production, product registration, and distribution of Class II medical devices related to stem cell extracellular vesicle products.
Enterprise Production License
Medical device production filing certificate
粤穗食药监械生产备20210002号
Product Registration License (1)
Medical device product filing
粤穗械备20210011号
Product Registration License (2)
Medical device product filing
粤穗械备20210009号
Class II Medical Device Operation License
Medical device distribution permit
粤穗食药监械经营备20220325号
Core Invention Patents: Extracellular Vesicle Technology
Three foundational invention patents covering the complete workflow from culture medium design to vesicle isolation and final formulation.
Patent 1: Stem Cell Extracellular Vesicle Culture Medium and Isolation Method
A specialized culture medium for stem cell extracellular vesicle secretion, and a method for culturing and isolating umbilical cord mesenchymal stem cell extracellular vesicles.
Patent 2: Ultrafiltration Device and Vesicle Separation Method
A proprietary ultrafiltration device and method for separating stem cell extracellular vesicles with high purity and consistency.
Patent 3: Umbilical Cord Mesenchymal Stem Cell Extracellular Vesicle Formulation
A formulation of umbilical cord mesenchymal stem cell extracellular vesicles and its preparation method, covering the final product composition and manufacturing process.
Registered Trademarks
研华
Company brand trademark — used for domestic business and institutional communications.
GABT研华生物
International brand trademark — used for global partnership and scientific communications.
胚泌
Product line trademark — used for extracellular vesicle and cytokine product branding.
Advertising and Regulatory Approvals
Product communications in China are subject to regulatory review and approval.
| Approval Type | Reference Number |
|---|---|
| Guangdong Advertising Review Permit | 粤广审准许字【2022】第03151号 |
Additional approval numbers are available upon request for institutional review.
Quality Testing Certifications
Cleanroom facilities are tested and certified by accredited third-party institutions.
Testing Institution
Guangzhou Institute of Microbiology Co., Ltd.
CNAS Accreditation: L0823
ilac-MRA Recognized
Test Report
Report No.: JJ20220527
Test Date: April 21–23, 2022
Cleanroom Class: C (10,000 level)
Standard: GB 50457-2019
Broader Intellectual Property Portfolio
Beyond the three core EV patents, Yanhua Bio’s portfolio includes 28+ invention patents valued at over ¥150 million, covering:
3D Bioreactor Technology
Proprietary 3D全自动智能化微生物反应器 (South China first), enabling simulation of 260+ disease-specific growth environments.
Culture Medium Formulations
Specialized culture media for stem cell cultivation, immune cell induction, and cytokine production.
Purification Processes
Nano-scale filtration and purification methods for extracellular vesicle isolation with high purity and batch consistency.
Documentation Available for Partners
Qualified institutional partners can request copies of credentials and technical documentation for review.
| Document | Availability |
|---|---|
| Medical device production license | Available upon request |
| Product registration licenses | Available upon request |
| Class II medical device operation license | Available upon request |
| Patent certificates (core EV patents) | Available upon request |
| Trademark registration certificates | Available upon request |
| Cleanroom testing report (CNAS L0823) | Available upon request |
| Advertising review permits | Available upon request |
| Business license and operation permits | Available upon request |
Request Credential Documentation
For scientific, institutional, and partnership inquiries, our team can share verified copies of licenses, patents, and certifications.