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Wrist Blood Pressure Monitor
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref WRS-35GModel WRS-35E\AOJ-35A\AOJ-35B\AOJ-35C\AOJ-35D\AOJ-35E\AOJ-35F\AOJ-35G\WRS-35KRef WRS-35KRef AOJ-35FRef WRS-35H510(k) K213503Ref WRS-35C
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-35G EUDAMEDWRS-35K EUDAMEDAOJ-35F EUDAMEDWRS-35H EUDAMEDWRS-35C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972040114242 EUDAMED06972040112026 EUDAMED06972040111296 EUDAMED06972040111654 EUDAMED06972040113795 EUDAMED
- Basic UDI-DI
- 697204011AOJ35X188 EUDAMED
- Direct Marketing DI
- 06972040114242 EUDAMED06972040112026 EUDAMED06972040111296 EUDAMED06972040111654 EUDAMED06972040113795 EUDAMED
- 510(k) Number
- K213503 FDA 510(k)
- FDA Product Code
- DXN FDA 510(k)
- EMDN Code
- Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1130 FDA 510(k)
- Regulation Number
- 870.1130 FDA 510(k)
- Market of Registration
- Germany EUDAMEDHungary EUDAMED
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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 Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K213503 | Class IIa | Active |
| 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 (6)
- EUDAMED b2f848ec-cb5f-4a02-b86d-d582384fe365 61 fields · synced Oct 6, 2026
- EUDAMED 6329c163-3533-4a83-9c24-2a571b6b3e2e 61 fields · synced May 16, 2026
- EUDAMED 09915c3e-7116-43d3-b86c-a8ebfe079819 61 fields · synced May 18, 2026
- EUDAMED 8d9a3c9e-5c86-42d5-8cd2-983c207e2560 61 fields · synced May 18, 2026
- FDA 510(k) K213503 24 fields · synced May 18, 2026
- EUDAMED 9f27d7d0-1136-4534-8295-9fcf0bfe2a7a 61 fields · synced Jul 9, 2026