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Lepu Medical
EUDAMEDClass IIa (EU MDR)
Ref BP3Model BP3, BP3D, BP3K, HDM3, HDM3D, HDM3K
Identity
- Trade Name
- LEPU MEDICAL EUDAMED
- Device Name
- Blood Pressure Monitor EUDAMED
- Model / Reference
- BP3, BP3D, BP3K, HDM3, HDM3D, HDM3K EUDAMEDBP3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934440102984 EUDAMED
- Basic UDI-DI
- 69344401BP3DNG EUDAMED
- Direct Marketing DI
- 06934440102984 EUDAMED
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Lepu Medical by Shenzhen Viatom Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69344401BP3DNG | 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 (1)
- EUDAMED 391cde33-e81d-484b-985f-0c03c80e4003 61 fields · synced Jun 15, 2026