← Back to catalogue
Electronic Blood Pressure Monitor
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 92028001003Model YJ320,YJ321E,YJ326E510(k) K232814Ref 92026001002
Identity
- Trade Name
- Electronic Blood Pressure Monitor EUDAMED
- Device Name
- Electronic Blood Pressure Monitor EUDAMED
- Model / Reference
- YJ320,YJ321E,YJ326E EUDAMED92028001003 EUDAMED92026001002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975039338858 EUDAMED06975039333860 EUDAMED
- Basic UDI-DI
- 697503933YJ320KD EUDAMED
- Direct Marketing DI
- 06975039338858 EUDAMED06975039333860 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
Electronic Blood Pressure Monitor by Zhuhai Yueja Medical Device 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 | K232814 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697503933YJ320KD | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zhuhai Yueja Medical Device Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000026087
- Authorised Representative
- phoenix Medtech GmbH DE-AR-000007996
Sources (3)
- EUDAMED a33543da-47e8-4daf-8d07-ebb9836ca172 85 fields · synced Oct 6, 2026
- EUDAMED 484f43ca-3140-4a66-8613-b78a100e3f14 61 fields · synced May 17, 2026
- FDA 510(k) K232814 1 fields · synced May 18, 2026