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Hilo Band (Aktiia Bracelet G1)
EUDAMEDClass IIa (EU MDR)
Ref N/AModel G1
by Aktiia SA
Identity
- Trade Name
- Hilo Band (Aktiia Bracelet G1) EUDAMED
- Device Name
- Aktiia Bracelet G1 - Blood Pressure Monitor EUDAMED
- Model / Reference
- G1 EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 17649998849019 EUDAMED
- Basic UDI-DI
- 7649998849AKBraceletYW EUDAMED
- Direct Marketing DI
- 17649998849019 EUDAMED
- EMDN Code
- Z1203020599,Z12030282 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Hilo Band (Aktiia Bracelet G1) by Aktiia SA — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7649998849AKBraceletYW | Class IIa | Active |
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Manufacturer
- Manufacturer
- Aktiia SA
- EUDAMED SRN
- CH-MF-000015833
- Authorised Representative
- Veranex Germany GmbH DE-AR-000005578
Sources (1)
- EUDAMED 3873fb13-1618-4d81-be18-ee59e9751762 61 fields · synced Jul 19, 2026