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Arm Type Electronic Blood Pressure Monitor
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref REFModel BSX-513
Identity
- Trade Name
- Arm Type Electronic Blood Pressure Monitor EUDAMED
- Device Name
- Arm Type Electronic Blood Pressure Monitor EUDAMED
- Model / Reference
- BSX-513 EUDAMEDREF EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06920485306098 EUDAMED
- Basic UDI-DI
- B-06920485306098 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
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Arm Type Electronic Blood Pressure Monitor by Shenzhen Bsx Technology Electronics Co., Ltd. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K183058 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06920485306098 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Bsx Technology Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000015965
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 1898cd9f-c255-4060-81e0-3e81a4cd02ca 61 fields · synced Jun 19, 2026
- FDA 510(k) K183058 1 fields · synced May 18, 2026