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Prolife PX7 Premium
EUDAMEDClass IIa (EU MDR)
Ref BP168A (PX7 Premium)Model BP100A，BP101A，BP103A，BPCB0A-3H，BP163A，BP168A，BP122A，CUFF-A，CUFF-B，CUFF-C
Identity
- Trade Name
- Prolife PX7 Premium EUDAMED
- Device Name
- Blood Pressure Monitor EUDAMED
- Model / Reference
- BP100A，BP101A，BP103A，BPCB0A-3H，BP163A，BP168A，BP122A，CUFF-A，CUFF-B，CUFF-C EUDAMEDBP168A (PX7 Premium) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948158401222 EUDAMED
- Basic UDI-DI
- 69481584ARM02T4 EUDAMED
- Direct Marketing DI
- 06948158401222 EUDAMED
- EMDN Code
- Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Lithuania 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
Prolife PX7 Premium by Shenzhen Combei Technology Co., Ltd. — Class IIa — CE/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 | 69481584ARM02T4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Combei Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000016047
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED cc71b8d0-6469-4614-8237-7fa870b2b00b 61 fields · synced Oct 6, 2026