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Alfacheck SMART VOICE
EUDAMEDClass IIa (EU MDR)
Ref BBZ32-AA01Model BBZ32-AA01,BBZ32-AB01,BBZ32-BB01,BBZ32-DA01,BBZ32-DB01
Identity
- Trade Name
- Alfacheck SMART VOICE EUDAMED
- Device Name
- Blood Pressure Monitor EUDAMED
- Model / Reference
- BBZ32-AA01,BBZ32-AB01,BBZ32-BB01,BBZ32-DA01,BBZ32-DB01 EUDAMEDBBZ32-AA01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06932825304206 EUDAMED
- Basic UDI-DI
- 69328253BBZ32M4 EUDAMED
- Direct Marketing DI
- 06932825304206 EUDAMED
- EMDN Code
- Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Greece 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
Alfacheck SMART VOICE by Guangdong Transtek Medical Electronics 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 | 69328253BBZ32M4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Guangdong Transtek Medical Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000010684
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 57c095a5-5ca6-4d21-b9f9-feb68098fbfc 61 fields · synced Jun 20, 2026