Eu Mdd
Eu Md Class 2a
No Longer On The Market
๐ซ๐ฎ Finland
CloudHolter
Devices (same UDI-DI)
1
Certificates
1
Countries
2
Notified Bodies
1
Basic Information
- Primary DI
- D-FI-CA01-2017-1781GJ
- Basic UDI-DI Code
- B-FI-CA01-2017-1781GJ
- Reference
- 05
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- No Longer On The Market
- Manufacturer
- Oy Diagnostic Devices Development
Additional Description
The Holter ECG monitor CloudHolter is intended for the recording and storage of long-term 3 lead ECG-signal collected from ambulatory patients of age 18+ for detect-ing of Arrhythmias, efficacy of pharmacological treatment, and Pacemaker evaluation. The device is used by a trained person, who reviews the data after downloading and processing by Holter analysis software. Moreover, the device can connect with a patient's smartphone for ECG transfer to a remote server.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12050403 | ECG HOLTER RECORDERS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | VTT-C-12222-01-1200-628-17 | Eurofins Electric & Electronics Finland Oy | Expired |
Available In Countries
๐ช๐ธ Spain
๐ท๐ด Romania
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