# Coba Biomedical PTY (Ltd) (contract manufacturer, Bloemfontein Free State, ZA): 27 new FDA device listings, incl. hook, ophthalmic

**Score:** 70/100

| Field | Value |
|---|---|
| Establishment | Coba Biomedical PTY (Ltd) |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | Bloemfontein Free State, ZA |
| New listings | 27 |
| Devices | Hook, Ophthalmic; Spatula, Ophthalmic; Specula, Ophthalmic; Handle, Scalpel; Hook, Surgical, General & Plastic Surgery; Scissors, General, Surgical; Retractor, Non-Self-Retaining; Holder, Needle, Gastroenterologic; Curette, Surgical, General Use; Instrument, Manual, Surgical, General Use |
| Product codes | HNQ, HND, HNC, GDZ, GDG, LRW, FGN, FHQ, FZS, MDM, HNA, DWS, EMF, HOE, GZX |
| Device classes | Class I, Class II |
| Medical specialties | Ophthalmic, General, Plastic Surgery, Gastroenterology, Urology, Cardiovascular, Neurology |
| First new listing | 2026-06-02 |
| Latest new listing | 2026-06-02 |
| FDA registration number | 3042940336 |
| Registration expires | 2026-12-31 |

## Why this score
- Contract manufacturer or sterilizer adding work.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.