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wrist blood pressure monitor
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref XY-W01BModel XY-W01A、XY-W01BRef XY-W01A
Identity
- Trade Name
- wrist blood pressure monitor EUDAMED
- Device Name
- wrist blood pressure monitor EUDAMED
- Model / Reference
- XY-W01A、XY-W01B EUDAMEDXY-W01B EUDAMEDXY-W01A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977093190090 EUDAMED06977093190083 EUDAMED
- Basic UDI-DI
- 697709319XYwRIST4C EUDAMED
- Direct Marketing DI
- 06977093190090 EUDAMED06977093190083 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 blood pressure monitor by Guangdong Xinyu Electronic and 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 | K241634 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697709319XYwRIST4C | Class IIa | Active |
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Manufacturer
- Manufacturer
- Guangdong Xinyu Electronic and Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000025849
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (3)
- EUDAMED 897070d9-0525-41a0-bb1a-a76c31215149 61 fields · synced Oct 6, 2026
- EUDAMED a973f983-4469-47a6-92d6-37dff432ae9f 61 fields · synced May 19, 2026
- FDA 510(k) K241634 1 fields · synced May 18, 2026