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Arm blood pressure monitor cuff
EUDAMEDClass I (EU MDR)
Ref CUFF(32-52cm)Ref CUFF(22-42cm)
Identity
- Trade Name
- Arm blood pressure monitor cuff EUDAMED
- Device Name
- CUFF-A EUDAMED
- Model / Reference
- CUFF(32-52cm) EUDAMEDCUFF(22-42cm) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948158400720 EUDAMED06948158400713 EUDAMED
- Basic UDI-DI
- 69481584CUFF-AUA EUDAMED
- Direct Marketing DI
- 06948158400720 EUDAMED06948158400713 EUDAMED
- EMDN Code
- Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Arm blood pressure monitor cuff by Shenzhen Combei Technology Co., Ltd. — Class I — 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 | 69481584CUFF-AUA | Class I | 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 (2)
- EUDAMED d05ddcb0-5aba-40a7-8b6c-4d09d4819a11 61 fields · synced Oct 6, 2026
- EUDAMED d637b42c-6611-4900-9cca-6cd0a081ef38 61 fields · synced May 17, 2026