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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 download and verification.

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 Reference: MDF G0156
Full legal policies: View all policies

Company Registration

CIPC Company Registration Certificate
Certificate of incorporation issued by the Companies and Intellectual Property Commission of South Africa.
Memorandum of Incorporation
Standard Memorandum of Incorporation (MOI) governing G 1 Healthcare (Pty) Ltd.

Regulatory & Product Licensing

SAHPRA License (Ref. MDF G0156)
South African Health Products Regulatory Authority medical device license.
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.