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Blood Pressure Monitors
EUDAMEDClass IIa (EU MDR)
Ref 99-13866A0-P81Model BP106A，BP866A，BP105A，BP108A，BPCB0A-2A，BP126A
Identity
- Device Name
- Blood Pressure Monitors EUDAMED
- Model / Reference
- BP106A，BP866A，BP105A，BP108A，BPCB0A-2A，BP126A EUDAMED99-13866A0-P81 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03830067460571 EUDAMED
- Basic UDI-DI
- 69481584ARM04T8 EUDAMED
- Direct Marketing DI
- 03830067460571 EUDAMED
- EMDN Code
- Z1203020599 NON-INVASIVE BLOOD PRESSURE GAUGES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Slovenia 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
Blood Pressure Monitors 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 4252dc7a-2dfe-469a-aa29-5afb13fcf172 61 fields · synced Oct 6, 2026