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Wrist Type Blood Pressure Monitor
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref YK-BPW2Ref YK-BPW4Ref YK-BPW3Ref YK-BPW1
Identity
- Device Name
- Wrist Type Blood Pressure Monitor EUDAMED
- Model / Reference
- YK-BPW2 EUDAMEDYK-BPW4 EUDAMEDYK-BPW3 EUDAMEDYK-BPW1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06921745207025 EUDAMED06921745200491 EUDAMED06921745207032 EUDAMED06921745207018 EUDAMED
- Basic UDI-DI
- B-06921745207025 EUDAMED69217452WBPMV6 EUDAMEDB-06921745207032 EUDAMEDB-06921745207018 EUDAMED
- Direct Marketing DI
- 06921745200491 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
Wrist Type Blood Pressure Monitor by Xuzhou Yongkang Electronic Science Technology Co., Ltd — Class IIa — FDA_510K, MDR, MDD — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K162616 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | B-06921745207025 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06921745207025 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000018890
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (5)
- EUDAMED fb018d39-332e-4107-bbc2-42f782016780 61 fields · synced Oct 6, 2026
- EUDAMED de55b4e8-cca1-4b13-a330-dc6a0adb7bba 61 fields · synced May 17, 2026
- EUDAMED 9e7f9c2e-dc90-451d-afd3-706bb1acf1e2 61 fields · synced May 17, 2026
- EUDAMED e6fa0fe3-61f8-4f67-999f-9722d6151864 61 fields · synced May 19, 2026
- FDA 510(k) K162616 1 fields · synced May 18, 2026