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Wrist Blood Pressure Monitor
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref AOJ-35AModel WRS-35E\AOJ-35A\AOJ-35B\AOJ-35C\AOJ-35D\AOJ-35E\AOJ-35F\AOJ-35G\WRS-35K510(k) K250161
Identity
- Trade Name
- Wrist Blood Pressure Monitor EUDAMED
- Device Name
- Wrist Blood Pressure Monitor EUDAMED
- Model / Reference
- WRS-35E\AOJ-35A\AOJ-35B\AOJ-35C\AOJ-35D\AOJ-35E\AOJ-35F\AOJ-35G\WRS-35K EUDAMEDAOJ-35A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972040110800 EUDAMED
- Basic UDI-DI
- 697204011AOJ35X188 EUDAMED
- Direct Marketing DI
- 06972040110800 EUDAMED
- EMDN Code
- Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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 Shenzhen AOJ Medical 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 Unknown
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250161 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697204011AOJ35X188 | Class IIa | Unknown |
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Manufacturer
- Manufacturer
- Shenzhen AOJ Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000018386
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (2)
- EUDAMED 4a76e0e1-3930-4060-ad30-96bf69afb9ec 85 fields · synced Jun 18, 2026
- FDA 510(k) K250161 1 fields · synced May 18, 2026