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

Name: FDA-Approved Class 1 Therapeutic Exosomes for Inflammation Control – Medical Device Submission ID
Brand: Sichuan Exosome Innovation Biological Technology Co., Ltd
SKU: 2 bottles of 5ml
Availability: InStock

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

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:

Active targeting: CD47-mediated immune evasion and inflammation-site homing
Multi-modal action: Simultaneous cytokine modulation (IL-10↑, TNF-α↓) and tissue repair promotion
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:

Cell Preservation Solution Medical FDA Approved Exosomes For Skin Cell Storage / Cosmetic R&D Keeps Cells Active & Stable

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