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Certifications & Compliance Documents

G1 Healthcare is a registered South African company. Below are our official company registration records and product regulatory documentation, available for on-screen verification.

Official certificates and licences are shown as a watermarked, view-only preview to prevent misuse. They are not available for direct download. To independently verify our registration, contact support@g1healthcare.co.zaor check SAHPRA's public register directly.
G 1 Healthcare (Pty) Ltd
Registration Number: 2025/451756/07 · Private Company, In Business · Director: S. Tripathi
Registered Office: 3 Inglenook Road, Riverside Lifestyle Estate, House 14, Nahoon Valley Park, Eastern Cape, 5202, South Africa
SAHPRA Distribution Licence No.: 00005410MD (Class B medical devices — distribution & import, valid until 03 March 2031)
Full legal policies: View all policies

Company Registration

Regulatory & Product Licensing

G1 Ostomy Bag — Redesigned SA Edition
Product design and specification overview for the South African market edition.
Product Structure (English Translation)
Detailed technical breakdown of product materials and construction.

ISO 10993 Biocompatibility & Safety Testing

In Vitro Cytotoxicity Test Report
ISO 10993-5:2009 cytotoxicity testing results.
Skin Irritation Test Report
ISO 10993-10:2010 skin irritation testing results.
Skin Sensitization Test Report
ISO 10993-10:2010 skin sensitization testing results.
Urostomy System MSDS
Material Safety Data Sheet for the one-piece urostomy system.