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Arm blood pressure monitor
EUDAMEDClass IIa (EU MDR)
Ref BP156AModel BP200A，BP116A，BP800A，BP156A，BP136A
Identity
- Trade Name
- Arm blood pressure monitor EUDAMED
- Device Name
- Blood Pressure Monitors EUDAMED
- Model / Reference
- BP200A，BP116A，BP800A，BP156A，BP136A EUDAMEDBP156A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948158401055 EUDAMED
- Basic UDI-DI
- 69481584ARM01T2 EUDAMED
- Direct Marketing DI
- 06948158401055 EUDAMED
- EMDN Code
- Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
Arm blood pressure monitor 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 | 69481584ARM01T2 | 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 1f0b345b-d04e-4c96-8489-4bca11b77730 61 fields · synced Oct 6, 2026