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Alvita
EUDAMEDClass I (EU MDR)
Ref Class I Medical Device according to rule 1Model AC2242-10
Identity
- Trade Name
- Alvita EUDAMED
- Device Name
- Cuff EUDAMED
- Model / Reference
- AC2242-10 EUDAMEDClass I Medical Device according to rule 1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06932825304060 EUDAMED
- Basic UDI-DI
- 69328253CUFFTV EUDAMED
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania 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
Alvita by Guangdong Transtek Medical Electronics 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 | 69328253CUFFTV | Class I | Active |
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Manufacturer
- Manufacturer
- Guangdong Transtek Medical Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000010684
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (1)
- EUDAMED d1083f7d-4469-484b-99e9-017ef1b42c7e 61 fields · synced Oct 6, 2026