# HARMAC MEDICAL PRODUCTS, INC./H3 de Tijuana, S. de RL de C.V. (contract manufacturer, Tijuana Baja California, MX): 27 new FDA device listings, incl. unit, phacofragmentation

**Score:** 70/100

| Field | Value |
|---|---|
| Establishment | HARMAC MEDICAL PRODUCTS, INC./H3 de Tijuana, S. de RL de C.V. |
| Owner / operator | Harmac Medical Products, Inc. |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | Tijuana Baja California, MX |
| New listings | 27 |
| Devices | Unit, Phacofragmentation; Endoilluminator; Cannula, Trocar, Ophthalmic; Cannula, Ophthalmic; Media, Corneal Storage; Apparatus, Cautery, Radiofrequency, Ac-Powered; Instrument, Vitreous Aspiration And Cutting, Ac-Powered; Photocoagulator And Accessories; Laser, Ophthalmic; Knife, Ophthalmic |
| Product codes | HQC, MPA, NGY, HMX, LYX, HQR, HQE, HQB, HQF, HNN, HOY, MDM, GZX, KKX |
| Device classes | Class I, Class II, Unclassified |
| Medical specialties | Ophthalmic, Gastroenterology, Urology, General, Plastic Surgery, Neurology |
| First new listing | 2026-05-08 |
| Latest new listing | 2026-05-27 |
| FDA registration number | 3045817901 |
| Registration expires | 2027-12-31 |

## 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: 2026-11-04T21:52:36.524Z.
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.