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Wrist Blood Pressure Monitor
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AOJ-35BModel 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 EUDAMEDN/A FDA UDI
- Generic Name
- Patient monitoring system module, blood pressure, noninvasive FDA UDI
- 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-35B EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972040110572 EUDAMEDFDA UDI
- Basic UDI-DI
- 697204011AOJ35X188 EUDAMED
- Direct Marketing DI
- 06972040110572 EUDAMED
- 510(k) Number
- K191180 FDA UDI
- FDA Product Code
- DXN FDA UDI
- EMDN Code
- Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMED
- GMDN Term
- Patient monitoring system module, blood pressure, noninvasive FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1130 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Wrist Blood Pressure Monitor by Shenzhen AOJ Medical Technology Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697204011AOJ35X188 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 897c6dfa-5df2-485b-b90c-4d127cd9b0ef 61 fields · synced Oct 6, 2026
- FDA UDI cc2da370-9b3e-4bbc-9320-412609ed0d1d 33 fields · synced May 30, 2026