Identity
- Trade Name
- Wellue FDA UDI
- Generic Name
- Manual-inflation electronic sphygmomanometer, portable FDA UDI
- Device Name
- Blood Pressure Monitor EUDAMED
- Model / Reference
- BP1 EUDAMEDAirBP Blood Pressure Monitor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06934440100720 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06934440100720 EUDAMED
- 510(k) Number
- K190207 FDA UDI
- FDA Product Code
- DXN FDA UDI
- EMDN Code
- Z1203020202 TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS EUDAMED
- GMDN Term
- Manual-inflation electronic sphygmomanometer, portable 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
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
No
FDA UDI
MR Unsafe FDA UDI
Blood Pressure Monitor by Shenzhen Viatom Technology Co., Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06934440100720 | 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
- Wellkang Ltd XI-AR-000001836
Sources (2)
- EUDAMED cd8a8ec5-84e7-4723-8c29-fc07cbd00602 61 fields · synced Oct 6, 2026
- FDA UDI 07174c40-e8a0-4fc4-889a-4ecc0df8094e 33 fields · synced May 29, 2026