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Upper Arm Blood Pressure Monitor
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref ZK-B876
Identity
- Trade Name
- Upper Arm Blood Pressure Monitor EUDAMED
- Model / Reference
- ZK-B876 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06922119300120 EUDAMED
- Basic UDI-DI
- B-06922119300120 EUDAMED
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Upper Arm Blood Pressure Monitor by Shenzhen Zhengkang Technology 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 | K191894 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06922119300120 | Class IIa | Active |
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Manufacturer
- Manufacturer
- ShenZhen ZhengKang Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000038997
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 8b89cfa7-c191-418e-8c6e-c7d9e2554370 61 fields · synced Oct 6, 2026
- FDA 510(k) K191894 1 fields · synced May 18, 2026