Devices (same UDI-DI)
1
Certificates
1
Countries
2
Notified Bodies
1
Basic Information
- Primary DI
- 04260732640035
- Basic UDI-DI Code
- B-04260732640035
- Reference
- 01-100
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- AthenaDiaX GmbH
Additional Description
Wearable sensor for long term recording of heart signals
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12050403 | ECG HOLTER RECORDERS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex IV | Z-17-172-P | Berlin Cert Prüf- und Zertifizierstelle für Medizinprodukte GmbH |
Available In Countries
🇩🇪 Germany
🇮🇹 Italy
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