Identity
- Trade Name
- CUFF(22-42cm) EUDAMED
- Device Name
- CUFF-A EUDAMED
- Model / Reference
- Soft Cuff M-L22-42cm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948158400539 EUDAMED
- Basic UDI-DI
- 69481584CUFF-AUA EUDAMED
- Direct Marketing DI
- 06948158400539 EUDAMED
- EMDN Code
- Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMED
Classification
- Device Class
- Class I 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
CUFF(22-42cm) 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Combei Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000016047
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED d61a89e6-6603-4991-91aa-e157c88aa96a 61 fields · synced Oct 6, 2026