Identity
- Trade Name
- BB-613 H&H Kit EUDAMED
- Device Name
- Non-invasive wearable medical device for continuous monitoring of vital signs EUDAMED
- Model / Reference
- BB-613 Series EUDAMEDBB90000200003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290020154316 EUDAMED
- Basic UDI-DI
- 6934931061BB613XN EUDAMED
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
Classification
- Device Class
- Class IIa 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
BB-613 H&H Kit by Biobeat Technologies LTD — 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 | 6934931061BB613XN | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biobeat Technologies LTD
- EUDAMED SRN
- IL-MF-000029965
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED ea29727a-b303-49f1-a587-21f8c354ab75 61 fields · synced Jun 9, 2026