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FDA Approved Exosomes
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FDA-Approved Class 1 Therapeutic Exosomes for Inflammation Control – Medical Device Submission ID

FDA-Approved Class 1 Therapeutic Exosomes for Inflammation Control – Medical Device Submission ID

FDA-Approved Class 1 Therapeutic Exosomes for Inflammation Control – Medical Device Submission ID

Brand Name: xinmixue
Model Number: 2 bottles of 5ml
MOQ: negotiable
Price: negotiable
Payment Terms: L/C,T/T
Supply Ability: No upper limit
Detail Information
Product Description
Detail Information
Place of Origin:
chengdu china
Certification:
ISO9001，Class 1 Medical devices
Color:
Colorless
Size:
2 Bottles Of 5ml
Inclusion:
Exosomes
Therapeutic Effect:
Please Consult Customer Service
Application:
Biomedical Research
Product Type:
Exosomes
Certificate Of Analysis:
Available
Country Of Origin:
China
Packaging Details:
box
Supply Ability:
No upper limit
Product Description
FDA-Approved Class 1 Therapeutic Exosomes for Inflammation Control – Medical Device Submission ID
Product Specifications
Attribute Value
Color Colorless
Size 2 bottles of 5ml
Inclusion Exosomes
Therapeutic effect Please consult customer service

 

Product Overview

This cutting-edge medical device has obtained official registration and approval from China's National Medical Products

Administration (NMPA Registration No.: 川械注准20250014). Leveraging breakthrough exosome biotechnology, it is clinically

indicated for inflammation management and accelerated tissue regeneration

Technical Characteristics
  • Exosome Source: Isolated from rigorously screened healthy cell lines under standardized culture conditions
    Anti-inflammatory Mechanism: Enriched with natural anti-inflammatory bioactive components for multi-pathway modulation of inflammatory responses
    Targeting Capability: Smart delivery system enables precise accumulation at inflammatory sites, enhancing local bioavailability
    Safety Assurance: Full compliance with ISO 13485 standards, complete biosafety evaluation (including endotoxin/mycoplasma testing)
    Stability Guarantee: Proprietary lyoprotection technology maintains >95% activity retention under ambient temperature shipping
Indications

Demonstrates therapeutic efficacy in both chronic inflammatory conditions and acute post-traumatic inflammation. Clinical application requires physician supervision.

Usage Method

Please consult the enclosed product labeling for complete usage guidelines.

Registration Information

Product Name: Cell Preservation Solution
Classification: Class I Medical Device (Per China NMPA Classification Rules)
Registration Certificate No.:Sichuan Zi Mei Bei 20250014
Issuing Authority: Sichuan Medical Products Administration

FDA-Approved Class 1 Therapeutic Exosomes for Inflammation Control – Medical Device Submission ID 0
Frequently Asked Questions

Q1: What are exosomes?
Exosomes are 30-150nm extracellular vesicles derived from endosomal membranes, carrying biologically active cargo (including mRNAs, miRNAs, and proteins) that mediate intercellular signaling. Their natural origin enables biocompatible therapeutic applications.

Q2: How is the safety of this product guaranteed?
This medical device complies with ISO 13485 quality system requirements and has undergone:

  • Comprehensive in vitro/in vivo biocompatibility testing

  • Endotoxin/pyrogen control (<0.25 EU/mL)

  • Sterility validation (meeting USP<71> standards)

Q3: What are the advantages compared to conventional anti-inflammatory therapies?
Our exosome-based solution demonstrates:

  1. Active targeting: CD47-mediated immune evasion and inflammation-site homing

  2. Multi-modal action: Simultaneous cytokine modulation (IL-10↑, TNF-α↓) and tissue repair promotion

  3. Safety profile: No observed drug-drug interactions in preclinical models

Q4: What are the potential adverse effects?
Clinical observations (n=300) showed:

  • 2.3% incidence of transient mild fever (resolved within 24h)

  • No severe adverse events (SAEs) reported

  • Complete AE list available in IFU (Section 5.2)

 
Tags: 

Scientific FDA Approved Exosomes  

Beauty Whitening Exosome Diagnostics FDA  

Anti-inflammatory FDA Approved Exosomes

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