Eu Mdr
Eu Md Class 2a
On The Market
🇨🇭 Switzerland
Hilo Spot (Aktiia Bracelet G2)
Devices (same UDI-DI)
1
Certificates
0
Countries
1
Notified Bodies
0
Basic Information
- Primary DI
- 17649998849040
- Basic UDI-DI Code
- 7649998849AKG2R7
- Reference
- N/A
- Device Types
-
Single use
- Regulation
- Eu Mdr
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Aktiia SA
Additional Description
Hilo Spot is a non-invasive blood pressure (BP) monitor intended to measure optical Photo-plethysmography (PPG) signals on the user’s wrist or fingertip and to calculate blood pressure values using a Pulse Wave Analysis (PWA) technique. Hilo Spot can also calculate heart rate based on the same measurement and analysis technology.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12030282 | VITAL SIGNS MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES |
| Z1203020599 | NON-INVASIVE BLOOD PRESSURE GAUGES - OTHER |
Available In Countries
🇩🇪 Germany
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