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Bb-613 Bpm Kit
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref BB900002000002Model BB-613 Series
Identity
- Trade Name
- BB-613 BPM KIT EUDAMED
- Device Name
- Non-invasive wearable medical device for continuous monitoring of vital signs EUDAMED
- Model / Reference
- BB-613 Series EUDAMEDBB900002000002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290020154439 EUDAMED
- Basic UDI-DI
- 6934931061BB613XN EUDAMED
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden 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 Bpm Kit by Biobeat Technologies LTD — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K241066 | Class IIa | Active |
| 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 (2)
- EUDAMED c0b49c1c-b3d6-42ec-b484-9a0245327185 61 fields · synced Jul 9, 2026
- FDA 510(k) K241066 1 fields · synced May 18, 2026