# Leica Instruments (Shanghai) Co., Ltd. (contract manufacturer, Shanghai, CN): 1 new FDA device listing, incl. whole slide imaging system

**Score:** 55/100

| Field | Value |
|---|---|
| Establishment | Leica Instruments (Shanghai) Co., Ltd. |
| Owner / operator | Leica Biosystems, division of Leica Microsystems, Inc. |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | Shanghai, CN |
| New listings | 1 |
| Devices | Whole Slide Imaging System |
| Product codes | PSY |
| Device classes | Class II |
| Medical specialties | Pathology |
| Brand names | Aperio GT 180 DX; Aperio GT 450 DX |
| First new listing | 2026-09-04 |
| Latest new listing | 2026-09-04 |
| FDA registration number | 3006610913 |
| Registration expires | 2026-12-31 |

## Why this score
- Contract manufacturer or sterilizer adding work.
- 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: 2026-11-04T21:52:36.524Z.
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.