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INTRASITE GEL - ARCSA Registration 971589ae52fea68e7addf3c34c2d700d

Access comprehensive regulatory information for INTRASITE GEL in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 971589ae52fea68e7addf3c34c2d700d and manufactured by SMITH & NEPHEW MEDICAL (SUZHOU) LIMITED. The device was registered on February 19, 2021.

This page provides complete registration details including product type (No Invasive), manufacturer information, authorized representative details, and regulatory compliance data from the official Ecuador ARCSA medical device database. Pure Global AI offers free access to Ecuador's complete medical device registry.

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ARCSA Official Data
III
971589ae52fea68e7addf3c34c2d700d
INTRASITE GEL
ARCSA ID: 971589ae52fea68e7addf3c34c2d700d
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Device Classification
Risk Class
III
Product Type
No Invasive
Brand Name
INTRASITE GEL
Commercial Name
รpositos
Registration Information
Analysis ID
971589ae52fea68e7addf3c34c2d700d
Registration Date
February 19, 2021
Expiration Date
February 19, 2026
Product Use

IT IS INDICATED FOR THE REMOVAL OF NECROTIC TISSUE FROM SUPERFICIAL, DEEP AND UNDERMINED (E.G. PRESSURE ULCERS, LEG ULCERS, FOOT ULCERS DIABETIC, MALIGNANT LESIONS, BURNS, SURGICAL INJURIES, SCALDS, LACERATIONS, CHAFING, AMPUTATIONS AND ULCERS FUNGAL). ALSO FOR TREATMENT OF CAVITATED LESIONS IN STATE OF GRANULATION, SLAGGED SKIN AND BURNS CAUSED BY RADIATION.

Manufacturer
City
SUZHOU, JIANGSU PROVINCE
Country
CHINA
Address
Nยฐ.12, WUAXIANG ROAD, COMPREHENSIVE FREE ZONE, WEST ZONE, SUZHOU INDUSTRIAL PARK,SUZHOU, JIANGSU PROVINCE
Product Owner
Name
SMITH & NEPHEW MEDICAL LIMITED
Country
UNITED KINGDOM OF GREAT BRITAIN
Authorized Representative
Address
STREET: AVENIDA ORELLANA NUMBER: S/N INTERSECTION:AVENIDA AMAZONAS
Phone
2232060