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Hilo Band
EUDAMEDClass IIa (EU MDR)
Ref HILO BPM-004-U (S)-G1Model G1
by Aktiia SA
Identity
- Trade Name
- Hilo Band EUDAMED
- Device Name
- Aktiia Bracelet G1 - Blood Pressure Monitor EUDAMED
- Model / Reference
- G1 EUDAMEDHILO BPM-004-U (S)-G1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 17649998849088 EUDAMED
- Basic UDI-DI
- 7649998849AKBraceletYW EUDAMED
- Direct Marketing DI
- 17649998849088 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 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 ea186ff1-2809-4196-ba16-b6d4826efdcc 61 fields · synced Jun 18, 2026