Identity
- Trade Name
- LEPU MEDICAL EUDAMEDFDA 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
- 06934440102588 EUDAMEDFDA UDI
- Basic UDI-DI
- 69344401BP2XD EUDAMED
- Direct Marketing DI
- 06934440102588 EUDAMED
- 510(k) Number
- K193348 FDA UDI
- FDA Product Code
- DXN FDA UDIDPS 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
- 870.1130 FDA UDI870.2340 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
Lepu Medical by Shenzhen Viatom Technology Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 69344401BP2XD | 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 (2)
- EUDAMED eb4794f8-f206-428d-ac9b-9b5d01e412dc 61 fields · synced Jun 15, 2026
- FDA UDI 5554b587-be8d-46f5-a02f-c446186dd75e 33 fields · synced May 30, 2026