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Blood Pressure Monitor
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref BP2Model BP2，BP2B，BP2V，BP2W
Identity
- Trade Name
- BP2 Blood Pressure Monitor FDA UDI
- Generic Name
- Electrocardiograph, home-use FDA UDI
- Device Name
- Blood Pressure Monitor EUDAMED
- Model / Reference
- BP2，BP2B，BP2V，BP2W EUDAMEDBP2 EUDAMEDBP2 Blood Pressure Monitor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06934440102618 EUDAMEDFDA UDI
- Basic UDI-DI
- 69344401BP2XD EUDAMED
- Direct Marketing DI
- 06934440102618 EUDAMED
- 510(k) Number
- K193348 FDA UDI
- FDA Product Code
- DPS FDA UDIDXN FDA UDI
- EMDN Code
- Z1203020302,Z12050301 EUDAMED
- GMDN Term
- Electrocardiograph, home-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2340 FDA UDI870.1130 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
Yes
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 — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
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 | K190207 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K193348 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69344401BP2XD | Class IIa | Active |
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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 (3)
- EUDAMED d4182e5f-a0dc-4a9b-8729-5de300b3f0bd 61 fields · synced Oct 6, 2026
- FDA UDI 87ea64a5-be77-43bd-9582-7b2c26743700 33 fields · synced May 29, 2026
- FDA 510(k) K190207 1 fields · synced May 18, 2026