MD Atlas update: Jun 28, 2026

Ophthalmica (Pty) Ltd

ZA-MF-000049091

Active

Address: 55 Regency Drive, Route 21 Corporate Park, 0178 Pretoria
Role: Manufacturer
Date of registration: Aug 11, 2025
Country: South Africa

Ophthalmica (Pty) Ltd is a medical device manufacturer registered in EUDAMED. Headquartered in Pretoria, South Africa. Explore the regulatory profile, devices and certificates on MD Atlas.

About Ophthalmica

: ZA-MF-000049091
Role: Manufacturer
Country: South Africa
Organization name: Ophthalmica (Pty) Ltd
EU VAT number: Not applicable
Date of registration: Aug 11, 2025

Contact details for Ophthalmica

Email: dalene.s@southmed.co.za
Address: 55 REGENCY DRIVE, ROUTE 21 CORPORATE PARK IRENE 0178 PRETORIA SOUTH AFRICA

Competent authority

Name: DE/CA09 - Staatliches Gewerbeaufsichtsamt Hannover

Phone: -
Email: poststelle@gaa-h.niedersachsen.de

Officers and regulatory representatives of Ophthalmica

STYGER Dalene
As per Article 15 of the EU MDR 2017/745: Conformity of the product device to the Medical Device Regulation and Quality Management System Conformity of the Technical Documentation and EU Declaration of conformity Compliance with Post-Market Surveillance (PMS) following Article 10(10) Compliance with the Vigilance Reporting obligations (Article 87 to 91) For Investigational devices: Issuance of a signed statement (Annex XV Chapter II Section 4.1)
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Ophthalmica (Pty) Ltd

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