Health Canada MDEL Listed
Licensed under Medical Device Establishment License #34625 for verified formulation purity and clinical facility deployment readiness.
Institutional Impact
Operational Benefits & Field Performance
Replacing static wall infrastructure with wearable point-of-need hand hygiene eliminates workflow interruptions, drives infection prevention compliance, and secures field staff across mission-critical environments.
Regulatory & Technical Standards
Third-Party Validated & Compliance Certified
CleanClip™ maintains compliance across clinical, governmental, and defense procurement frameworks.
Zero-RF EMSEC Compliant
Fully analogue deployment configurations verified free of wireless RF output, maintaining complete compatibility with EMSEC and TEMPEST secure zones.
Efficacy & Pathogen Clearance
Independently lab-tested 75% USP-grade Ethyl Alcohol formulation achieving 99.99% reduction of broad-spectrum viral and bacterial pathogens.
ISO 13485 Manufacturing
Produced under rigid ISO 13485 quality management standards ensuring precision meter valve tolerances and repeatable dose delivery.
DOT & IATA Hazmat Approved
Cartridge packaging and sealed multi-pack containers certified for secure ground and air logistics transit under UN1170 classification.
Offline Data Telemetry Security
USB-C encrypted dock logging complies with institutional data privacy rules, transferring compliance metrics without network connection risks.
Verification Matrix
Institutional Certification Registry
A summary of regulatory filings, standards, and third-party laboratory accreditations.
| Standard / License | Issuing Authority / Body | Registration ID | Compliance Scope |
|---|---|---|---|
| MDEL License | Health Canada | MDEL #34625 | Medical Device Formulation & Sales |
| EMSEC Zero-RF | Independent Testing Laboratory | VER-EMC-2025-09 | RF Emissions Exemption |
| Quality Standard | International Organization for Standardization | ISO 13485:2016 | Quality System Manufacturing |
| Dangerous Goods Transit | DOT / IATA | UN1170 Class 3 | Consumable Transport Safety |
Request Official Regulatory Documentation Package
Receive certified test results, Health Canada MDEL copies, and EMSEC compliance verification for audit review.