Edan Instruments, Inc. (contract manufacturer, Shenzhen Guangdong, CN): 13 new FDA device listings, incl. monitor, physiological, patient(with arrhythmia detection or alarms)
Edan Instruments, Inc. (Shenzhen Guangdong): 13 new FDA device listings, incl. monitor, physiological, patient(with arrhythmia detection or alarms). Its amount of 13 is top-decile (95th percentile of 2,570 records). Dated 85 days ago, it serves as a historical benchmark. Score 70/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 13 · 95th percentile of 2,570 DeviceEstablishmentPulse records · 13.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 499 related CN DeviceEstablishmentPulse records and the 5-column CSV export.
| 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 |
| amount percentile | 95th of 2,570 (median 1, 13.0x median) |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-08-11
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT
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Peer benchmark and outreach value: Edan Instruments, Inc. and 687 CN peers
- CN DeviceEstablishmentPulse records like this one: 687
- Edan Instruments, Inc.'s amount: 95th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every CN peer: $137,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
70 / 100 Score
- Contract manufacturer or sterilizer adding work.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
What is the DeviceEstablishmentPulse record for Edan Instruments, Inc. in Shenzhen Guangdong?
Edan Instruments, Inc. (Shenzhen Guangdong, CN), a contract manufacturer, added 13 FDA device listings between 2026-07-04 and 2026-08-11.
How does Edan Instruments, Inc. compare to other DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 13 is 13.0x the median of 1 across 2,570 records. It is 85 days old; check the official source for later updates before acting. Its Score of 70/100 puts it among the stronger signals in this feed.
Edan Instruments, Inc. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Edan Instruments, Inc. | Shenzhen Guangdong, CN | 13 | 95th | 2026-08-11 |
| Biopro, Inc. | Port Huron, MI | 11 | 94th | 2026-10-15 |
| Arthrex, Inc. | Ave Maria, FL | 10 | 93rd | 2026-09-27 |
| NGInstruments, Inc dba Avalign Cutting Instruments | Warsaw, IN | 4 | 83rd | 2026-10-16 |
Related records
DeviceEstablishmentPulse: Contract manufacturer DeviceEstablishmentPulse: Foreign establishment
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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.