# Edan Instruments, Inc. (contract manufacturer, Shenzhen Guangdong, CN): 13 new FDA device listings, incl. monitor, physiological, patient(with arrhythmia detection or alarms)

**Score:** 70/100

| Field | Value |
|---|---|
| Establishment | Edan Instruments, Inc. |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer); Manufacture Medical Device |
| Location | Shenzhen Guangdong, CN |
| New listings | 13 |
| Devices | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms); Electrocardiograph; Plethysmograph, Impedance; Oximeter; Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm); System, Measurement, Blood-Pressure, Non-Invasive; Continuous Measurement Thermometer; Monitor, St Segment With Alarm; System, Network And Communication, Physiological Monitors; Medical Device Data System |
| Product codes | MHX, DPS, DSB, DQA, DRT, DXN, FLL, MLD, MSX, OUG |
| Device classes | Class I, Class II |
| Medical specialties | Cardiovascular, General Hospital |
| Brand names | Vista 300; Vista 300 S; Electrocardiograph Model: SE-1202, SE-1202E; Telemetry Monitor Model: iT30, iT50; Vista CMS; Vista Gateway |
| First new listing | 2026-07-04 |
| Latest new listing | 2026-08-11 |
| FDA registration number | 3003971136 |
| 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.