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Arm blood pressure monitor
EUDAMEDClass IIa (EU MDR)
Ref XY-B09Model XY-B01、XY-B02、XY-B03、XY-B05、XY-B07、XY-B08、XY-B09
Identity
- Trade Name
- Arm blood pressure monitor EUDAMED
- Device Name
- Arm blood pressure monitor EUDAMED
- Model / Reference
- XY-B01、XY-B02、XY-B03、XY-B05、XY-B07、XY-B08、XY-B09 EUDAMEDXY-B09 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977093190076 EUDAMED
- Basic UDI-DI
- 697709319XYarm9L 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
Arm blood pressure monitor by Guangdong Xinyu Electronic and 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 | 697709319XYarm9L | Class IIa | Active |
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Manufacturer
- Manufacturer
- Guangdong Xinyu Electronic and Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000025849
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (1)
- EUDAMED 49028428-0f09-4882-b760-9e678ebc2694 61 fields · synced Jun 19, 2026