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Arm Type Electronic Blood Pressure Monitor
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref REFModel BSX516
Identity
- Trade Name
- BOTHEALTH FDA UDI
- Generic Name
- Patient monitoring system module, blood pressure, noninvasive FDA UDI
- Device Name
- Arm Type Electronic Blood Pressure Monitor EUDAMED
- Model / Reference
- BSX516 EUDAMEDFDA UDIREF EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06920485305169 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06920485305169 EUDAMED
- 510(k) Number
- K183058 FDA UDI
- FDA Product Code
- DXN FDA UDI
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
- GMDN Term
- Patient monitoring system module, blood pressure, noninvasive FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1130 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Arm Type Electronic Blood Pressure Monitor by Shenzhen Bsx Technology Electronics Co., Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06920485305169 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 0b8f47e1-3454-4e78-b240-5ffa686a575a 61 fields · synced Oct 6, 2026
- FDA UDI 9df8aa28-6000-45ac-b63a-ce8ce89763a1 33 fields · synced May 30, 2026