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Prolife PX6 Advanced
EUDAMEDClass IIa (EU MDR)
Ref BP126A（Prolife PX6 Advanced）Model BP106A，BP866A，BP105A，BP108A，BPCB0A-2A，BP126A
Identity
- Trade Name
- Prolife PX6 Advanced EUDAMED
- Device Name
- Blood Pressure Monitors EUDAMED
- Model / Reference
- BP106A，BP866A，BP105A，BP108A，BPCB0A-2A，BP126A EUDAMEDBP126A（Prolife PX6 Advanced） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948158401260 EUDAMED
- Basic UDI-DI
- 69481584ARM04T8 EUDAMED
- Direct Marketing DI
- 06948158401260 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 PX6 Advanced by Shenzhen Combei 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 | 69481584ARM04T8 | 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 3a137e93-4bf2-43eb-b493-3676680048e7 61 fields · synced Oct 6, 2026