EquiTrak Pro — Due Diligence
MedBalance GmbH · 🇩🇪 · Class IIb · CE + TGA
EquiTrak Pro
Postural Stability & Balance Diagnostics · Class IIb
CE CertifiedISO 13485ENT Focus
87
AI Score
Manufacturer
MedBalance GmbH, Frankfurt
Product Category
Vestibular / Balance Diagnostics
Device Class
IIb (EU) · Class B (India)
Existing Approvals
CE Mark · TGA (Australia)
Target Markets
India, UAE, Thailand, Singapore
Taevas Margin Target
28–34% gross margin
AI Assessment Scores
Clinical Relevance88/100
Market Fit91/100
Regulatory Pathway74/100
Competitive Position82/100
Financial Viability79/100
Technical Specifications
AI VerifiedPlatformMulti-axis force plate + VNG module
ConnectivityWi-Fi, Bluetooth 5.0, USB-C
Battery Life6 hours continuous use
Weight4.2 kg (portable version)
Display10.1" touch HD display
SoftwareCloud-based, AI analytics dashboard
EMCIEC 60601-1-2 compliant
SterilizationIP54 rated, wipe-down surfaces
✦ AI Advisor
•
EquiTrak Pro scores 87/100 — top 8% of all products assessed this year.
•
Regulatory pathway is the weakest dimension — CDSCO India will require local clinical data.
•
Market fit is exceptional: only 2 competitors in India balance diagnostics space.
•
Recommend fast-tracking clinical evidence review before finalising distribution terms.
Key Risks
HighCDSCO India may require local clinical study
MediumCE Mark expires Mar 2027 — renewal in progress
MediumAfter-sales service infrastructure needed
LowHindi IFU translation not yet started