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Wrist Blood Pressure Monitor
EUDAMEDClass IIa (EU MDR)
Ref WRS-35KModel WRS-35E\AOJ-35A\AOJ-35B\AOJ-35C\AOJ-35D\AOJ-35E\AOJ-35F\AOJ-35G\WRS-35K
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 EUDAMEDWRS-35K EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972040112743 EUDAMED
- Basic UDI-DI
- 697204011AOJ35X188 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 — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697204011AOJ35X188 | Class IIa | Active |
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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 (1)
- EUDAMED 5cfce981-082d-432e-839e-d9a51fcd38c8 61 fields · synced Oct 7, 2026