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Blood Pressure Monitor
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref BP2ARef BP1SRef HDM3Model BP3, BP3D, BP3K, HDM3, HDM3D, HDM3K
Identity
- Trade Name
- BP2A Blood Pressure Monitor FDA UDI
- Generic Name
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
- Device Name
- Blood Pressure Monitor EUDAMED
- Model / Reference
- BP2A EUDAMEDBP1S EUDAMEDBP3, BP3D, BP3K, HDM3, HDM3D, HDM3K EUDAMEDHDM3 EUDAMEDBP2A Blood Pressure Monitor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06934440102755 EUDAMEDFDA UDI06934440101567 EUDAMED06934440103998 EUDAMED
- Basic UDI-DI
- 69344401BP2AN7 EUDAMEDB-06934440101567 EUDAMED69344401BP3DNG EUDAMED
- Direct Marketing DI
- 06934440102755 EUDAMED06934440103998 EUDAMED
- 510(k) Number
- K193348 FDA UDI
- FDA Product Code
- DXN FDA UDI
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMEDZ1203020202 TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS EUDAMEDZ12050301 GENERAL PURPOSE ELECTROCARDIOGRAPHS EUDAMED
- GMDN Term
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist 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
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Blood Pressure Monitor by Shenzhen Viatom Technology Co., Ltd. — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 69344401BP2AN7 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69344401BP2AN7 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Viatom Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000012182
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (4)
- EUDAMED 015c4201-ea96-4a52-a316-fdef310ff82f 61 fields · synced Jul 16, 2026
- EUDAMED df7c21a3-1f63-4eaf-ac55-99c151be1d2c 61 fields · synced May 18, 2026
- FDA UDI c8adecdc-7b2a-4112-bc66-7dce7525eb81 33 fields · synced May 29, 2026
- EUDAMED dd93de85-a801-4561-ac41-7b7388d45afb 61 fields · synced Jul 8, 2026