Engage Medical Device Alarm Notification System (Emdan)
8 catalogue numbers from EMDAN 2.5.0, listed by Stryker GmbH, Switzerland, under System, Network And Communication, Physiological Monitors. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
8catalogue numbers in this listing
Who Else Makes It
All of them in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | MSX |
| Device type | System, Network And Communication, Physiological Monitors |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2300 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K130339 |
| Record published | 2023-01-27 |
| Record revised | 2023-10-05 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EMDAN 2.5.0 | In distribution | |
| EMDAN 1.10.0 | In distribution | |
| EMDAN 2.3.1 | In distribution | |
| EMDAN 2.4.0 | In distribution | |
| EMDAN 2.3.0 | In distribution | |
| EMDAN 2.1.1 | In distribution | |
| EMDAN 2.2.0 | In distribution | |
| EMDAN 2.1.0 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Messenger | Spok Inc. | 9 |
| eCareManager | Visicu, Inc. | 8 |
| BeneVision Central Monitoring System | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 7 |
| Xhibit | Spacelabs Healthcare (Washington), Inc | 4 |
| IntelliVue XDS Software | Philips Medizin Systeme Böblingen GmbH | 4 |
| Ascom | Ascom Sweden AB | 3 |
| Spacelabs Healthcare | Spacelabs Healthcare (Washington), Inc | 3 |
| Patient SafetyNet Console | Masimo Corporation | 3 |
| System, Network And Communication, Physiological Monitors | Philips Medical Systems Hsg | 3 |
| RescueNet 12-Lead | Zoll Medical Corporation | 2 |
| Telemetry Transmitter | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 2 |
| Current Health Wearable Monnitoring System | Current Health Ltd | 2 |
Showing 12 of 165. All products under System, Network And Communication, Physiological Monitors
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.