certificate ce
Cardiovascular Diagnostics EC Certificate CE Certificate
EC Certificate for Full Quality Assurance System according to Directive 93/42/EEC Annex II, covering cardiovascular diagnostic equipment and software.
Other versions of this product, each with its own page.
Available in 4, 5, or 10 wire configurations.
Disposable electrodes for signal acquisition.
Protective covers for the recorder.
Wearable strap for patient comfort.
certificate ce
EC Certificate for Full Quality Assurance System according to Directive 93/42/EEC Annex II, covering cardiovascular diagnostic equipment and software.
certificate other
Notified Body confirmation letter regarding the status of a formal application, written agreement, and surveillance under Regulation (EU) 2023/607 for AMEDTEC Medizintechnik Aue GmbH, confirming transitional provisions for medical devices.
certificate other
Notified Body confirmation letter from SLG Prüf- und Zertifizierungs GmbH regarding the status of MDR application and written agreement for AMEDTEC Medizintechnik Aue GmbH under Regulation (EU) 2023/607.
AMEDTEC Medizintechnik Aue GmbH
Connect directly with AMEDTEC Medizintechnik Aue GmbH to request pricing, samples and lead times for EP830 Holter Recorder.
The EP830 is a high-performance Holter ECG recorder designed for efficient clinical workflows. It enables rapid data download and visual inspection in under 60 seconds, with full diagnostic reports available in under 5 minutes.
| Dimensions | 80 x 59 x 18 mm |
|---|---|
| Weight | 63 g |
| Recording Channels | 3 or 12 |
| Recording Time (3-channel) | > 14 days |
| Recording Time (12-channel) | 2 days |
| AD Resolution | 24 bit |
| Sample Rate | 250, 500, or 1000 Hz |
| Frequency Response | 0.05 to 240 Hz |
| Battery Type | 1 AA (Alkaline, Lithium, or NiMH) |
| Waterproof Rating | IPX6 |