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Arm Type Blood Pressure Monitor
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref YK-BPA4
Identity
- Device Name
- Arm Type Blood Pressure Monitor EUDAMED
- Model / Reference
- YK-BPA4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06921745200453 EUDAMED
- Basic UDI-DI
- 69217452ABPMQC EUDAMED
- Direct Marketing DI
- 06921745200453 EUDAMED
- EMDN Code
- Z1203020302 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 Blood Pressure Monitor by Xuzhou Yongkang Electronic Science Technology Co., Ltd — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
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 | K183491 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69217452ABPMQC | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000018890
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (2)
- EUDAMED f745bf92-2f65-47e0-b237-62620b5db630 61 fields · synced Jun 18, 2026
- FDA 510(k) K183491 1 fields · synced May 18, 2026