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Arm Type Electronic Blood Pressure Monitor
EUDAMEDClass IIa (EU MDR)
Ref REFModel BSX583Model AC-9080Model BSX561,BSX593,BSX505,BSX508,BSX527,BSX595,BSX553,BSX516,BSX515,BSX525,BSX512,BSX556,BSX595E,BSX568Model BSX513
Identity
- Device Name
- Arm Type Electronic Blood Pressure Monitor EUDAMED
- Model / Reference
- BSX583 EUDAMEDREF EUDAMEDAC-9080 EUDAMEDBSX561,BSX593,BSX505,BSX508,BSX527,BSX595,BSX553,BSX516,BSX515,BSX525,BSX512,BSX556,BSX595E,BSX568 EUDAMEDBSX513 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06920485307507 EUDAMED06920485308269 EUDAMED06920485308382 EUDAMED06920485308375 EUDAMED06920485308436 EUDAMED
- Basic UDI-DI
- B-06920485307507 EUDAMEDB-06920485308269 EUDAMED69204853BSXA6PV EUDAMEDB-06920485308436 EUDAMED
- Direct Marketing DI
- 06920485308382 EUDAMED06920485308375 EUDAMED
- EMDN Code
- Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMEDZ1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS 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
Arm Type Electronic Blood Pressure Monitor by Shenzhen Bsx Technology Electronics Co., Ltd. — Class IIa — MDR, MDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06920485307507 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06920485307507 | 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 (5)
- EUDAMED bfc400ba-50c1-4916-a0ce-6e5597c47eae 61 fields · synced Aug 2, 2026
- EUDAMED d7ddbe96-c76f-4cc9-ae58-3b06d6e417b1 61 fields · synced May 17, 2026
- EUDAMED 20d89586-eef4-4128-9738-2c4c93ac6b3a 61 fields · synced Jul 18, 2026
- EUDAMED 45883802-5f7d-43ab-b0b6-d8f6a93abe43 61 fields · synced Jul 20, 2026
- EUDAMED 3921a649-faf3-4631-9550-dc180a89af37 61 fields · synced Aug 2, 2026