医療機器
ISO 13485 Certified Battery Solutions for Healthcare
Medical-grade batteries for health patches, monitors, and diagnostic devices with rigorous testing and compliance.
Market Overview
Market Size
$6.8B
Current market value
Growth Rate
15.2%
CAGR (2023-2028)
Projection
Expected to reach $13.2B by 2028
By 2028
Industry Challenges
Regulatory Compliance
Must meet FDA, CE, and ISO 13485 requirements for medical devices
Biocompatibility
Materials must be safe for prolonged skin contact and implantable applications
Reliability & Safety
Zero tolerance for failures in life-critical applications
Traceability
Complete batch traceability and documentation required
Extended Runtime
Patches must operate for 7-14 days on a single charge
JHY's Medical Solution
Fully compliant medical-grade batteries with ISO 13485 certification, biocompatible materials, and complete traceability.
Key Features
ISO 13485 medical device certification
FDA and CE approved manufacturing process
100% battery testing and quality assurance
0.1% defect rate guarantee
Complete batch traceability and documentation
Biocompatible materials for skin and implantable contact
技術仕様
Parameter
JHY Battery
Competitors
Certification
ISO 13485
Limited
Defect Rate
0.1%
0.5-1.0%
テスト
100% tested
Sample tested
Traceability
Full batch
Partial
Capacity Range
10-500mAh
20-300mAh
Operating Temp
-20°C to 60°C
-10°C ～ 50°C
Competitive Analysis
VARTA
✓ Strengths
Medical expertise
✗ Limitations
Limited customization, Higher cost
Grepow
✓ Strengths
Good capacity
✗ Limitations
Limited medical certification
EVE Energy
✓ Strengths
Reliable
✗ Limitations
Standard specs only
Real-World Applications
Health Monitoring Patches
Wearable patches for continuous health monitoring
Key Benefit:
7-14 day runtime with medical-grade reliability
Diagnostic Devices
Portable diagnostic equipment for clinics and hospitals
Key Benefit:
Reliable power for critical medical applications
Implantable Sensors
Biocompatible batteries for implanted medical devices
Key Benefit:
ISO 13485 certified for implantable applications
ROI Calculator
Estimate Your Savings
Unit Price
$5
Annual Units
100K
Cost Savings/Unit
$0.5
よくある質問
Are your batteries FDA approved?
+Our batteries are manufactured under ISO 13485 and meet FDA requirements for use in medical devices. Final FDA approval depends on your device classification; we provide documentation to support regulatory submissions.
What's your defect rate?
+We guarantee a 0.1% defect rate with 100% battery testing and continuous quality monitoring.
Can you provide batch traceability?
+Yes. Every batch is fully traceable with complete documentation including test records, material certificates, and production logs.
Are your materials biocompatible?
+Yes. We use biocompatible materials suitable for prolonged skin contact and implantable applications, tested per ISO 10993 requirements.
What's your lead time for medical device batteries?
+Standard medical device batteries ship in 4-6 weeks. Expedited production is available for urgent requirements.
Do you provide technical documentation?
+Yes. We provide datasheets, safety reports, certifications, and technical documentation to support regulatory submissions.
今すぐ始めましょう
Contact our team to discuss your specific requirements
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