# Labotech Microscopes India Private Limited (manufacturer, AMBALA CANTT Haryana, IN): 2 new FDA device listings, incl. colposcope (and colpomicroscope), exempt

**Score:** 60/100

| Field | Value |
|---|---|
| Establishment | Labotech Microscopes India Private Limited |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | AMBALA CANTT Haryana, IN |
| New listings | 2 |
| Devices | Colposcope (And Colpomicroscope), Exempt; Microscope, Surgical |
| Product codes | PTZ, EPT |
| Device classes | Class I, Class II |
| Medical specialties | Obstetrics/Gynecology, General, Plastic Surgery |
| Brand names | LABOMED PRIMA CS; LABOMED PRIMA GN; LABOMED PRIMA C PLUS; LABOMED PRIMA C; LABOMED MAGNA M; LABOMED PRIMA Zi; LABOMED PRIMA Z; LABOMED PRIMA DNTi |
| First new listing | 2026-08-27 |
| Latest new listing | 2026-08-27 |
| FDA registration number | 3005527296 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.

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.