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Hilo Backend
EUDAMEDClass IIa (EU MDR)
Ref 17649998849064Model Hilo Spot
by Aktiia SA
Identity
- Trade Name
- Hilo Backend EUDAMED
- Device Name
- Hilo Backend EUDAMED
- Model / Reference
- Hilo Spot EUDAMED17649998849064 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 17649998849064 EUDAMED
- Basic UDI-DI
- 7649998849AKBACKENDGH EUDAMED
- EMDN Code
- Z12030292 VITAL SIGNS MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE 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 Backend 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 | 7649998849AKBACKENDGH | 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 c8dcf54d-5e36-4956-82cd-970be05ab1f8 61 fields · synced Aug 1, 2026